GTP Bioways, a contract development and manufacturing company providing a unique service offering for the development of production processes and the manufacture of biotherapies, antibody-drug and nanomedicine conjugates, is investing 12 million euros in two new production lines of biomedicines at its Toulouse site.

A World Health Organization-led programme to ensure poorer countries get fair access to COVID-19 vaccines, tests and treatments aims to secure antiviral drugs for patients with mild symptoms for as little as $10 per course, a draft document seen by Reuters says.

Valneva SE, on Monday 18 october, said its experimental COVID-19 vaccine demonstrated efficacy "at least as good, if not better" than AstraZeneca's shot in a late-stage trial comparing the two, with significantly fewer adverse side effects.

Researchers in the Netherlands are developing laser technology to enable "virtually painless" injections without needles in what they call a breakthrough that will ease fear and lower the threshold for vaccinations.

The world of cancer research, diagnostics and therapeutics led its virtual congress on the European Society of Medical Oncology (ESMO) website for the second year in row due to the Covid-19 pandemic. Here are some of the main highlights of the biggest congress in Europe, as if you were attending the meetings

PCI Pharma Services (PCI), has signed a definitive agreement to acquire Lyophilization Services of New England, Inc. (LSNE), in Bedford, New Hampshire, from global private equity firm Permira, to add end-to-end global sterile fill-finish and lyophilization manufacturing capabilities

The favorable market dynamics across Lonza's businesses create attractive investment opportunities, reflected in the company's growth plans. Lonza is accelerating its de-risked long-term investment program to ensure it can capture increasing market demand and capitalize on future opportunities.

Cambrex is expanding its manufacturing center of excellence in High Point, NC. The $30+ million investment is designed to add new chemistry laboratories, two new clinical manufacturing suites and include a small-scale commercial manufacturing operation with three work centers and 2,000 Litre reactors.

GTP Bioways, specialist in the production of biotherapies and nano-therapies, has acquired the company IDBiotech based in Issoire (France), CRO specialized in the development and manufacture of immunoassays and the implementation of services analytical for the determination of target bio-molecules or HCP-type contaminants.

An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.

Thermo Fisher Scientific Inc. has assumed operational responsibility for a new biologics manufacturing site in Lengnau, Switzerland as part of its strategic partnership with CSL Limited announced last year. The Lengnau site will become part of Thermo Fisher's global biologics manufacturing network, and approximately 200 employees will join Thermo Fisher

Alcami, announced, Wednesday 19 september, an additional $31 million investment to expand its sterile development and manufacturing operation in Charleston, SC.

AbbVie Inc said, on Tuesday 28 september, the U.S. health regulator approved its once-daily oral medicine for preventive treatment of migraine in adults, adding a third drug to the drugmaker's arsenal of therapies for severe headaches.

Pfizer Inc has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus. The drugmaker and its rivals, including U.S.-based Merck & Co Inc and Swiss pharmaceutical Roche Holding AG, have been racing to develop an easy-to-administer antiviral pill for COVID-19.

Hikma Pharma has agreed to acquire Custopharm Inc. from Water Street Healthcare Partners Custopharm, a US-based generic sterile injectables company. The company specializes in developing a range of generic injectable products, including those with complex formulations

Three CDMOs are investing in Switzerland, Ireland and Denmark in new operational production units in 2023.

The "Green Deal" initiated by the European Commission aims at reducing the net emissions of greenhouse gases to zero across the EU by 2050, thereby making the European continent climate-neutral. In response to the increasing pressures to tackle climate change and curb carbon emissions, CDMO companies are moving aggressively towards becoming more sustainable.

Spanish pharmaceuticals company Grifols proposed a 1.6 billion euro ($1.9 billion) takeover of its German rival Biotest on Friday 17 september, in a move to consolidate the plasma-based drug industry.

ADQ, a holding company spanning key sectors of Abu Dhabi's diverse economy, has reached a definitive agreement to acquire Acino from its current shareholders, which include Nordic Capital and Avista Capital Partners.

If investors in China's biotech industry needed one more sign that the sector is coming of age, then a major licensing deal RemeGen Co Ltd struck last month with Seattle-based Seagen Inc fits the bill...

German biotech firm CureVac said on Tuesday it cancelled contract manufacturing deals for its experimental COVID-19 vaccine with two prospective partners, after rivals with approved shots have boosted production.

Takeda Pharmaceutical Co, which distributes Moderna Inc's COVID-19 shots in Japan, expects vaccines to become a bigger part of its portfolio as shots for dengue fever and COVID-19 near regulatory approval, its chief executive said.

Moderna Inc is developing a single vaccine that combines a booster dose against COVID-19 with its experimental flu shot. The company hopes to eventually add vaccines it is working on for respiratory syncytial virus (RSV) and other respiratory diseases as an annual shot...

French drugmaker Sanofi said on Wednesday 8 september, it would buy U.S. biopharmaceutical company Kadmon Holdings for 1.9 billion dollars, one month after announcing the purchase of another US biotech, Translate Bio for $3.2 billion. In April, Sanofi completed the purchase of Kymab Ltd., a maker of antibody treatments, for $1.1 billion upfront.

The fight against the Covid-19 and its numerous variants is not the only global health threat the world must cope with. Superbugs (or drug-resistant bacteria) becomes more dangerous and difficult to treat. All countries should prioritize increased access to antibiotics and intensify efforts to help develop urgently needed new ones

Bettera, based in Plano, Texas, and backed by private-equity firm Highlander Partners LP, manufactures gummy, soft-chew and lozenge forms of vitamins and supplements. Bettera has about 500 employees.

Pfizer Inc said on Monday 24 August it would buy Canadian drug developer Trillium Therapeutics Inc in a $2.26 billion deal to strengthen its arsenal of blood cancer therapies.

Pfizer Inc said on Monday 24 August it would buy Canadian drug developer Trillium Therapeutics Inc in a $2.26 billion deal to strengthen its arsenal of blood cancer therapies.

The pandemic has enabled us to study the details of how evolution happens - in real time. Scientists have generated more than two million genome sequences of the SARS-CoV-2 virus, allowing us to dissect the minutiae of evolutionary changes to a degree never previously possible for any replicating biological agent outside of the laboratory.

The mRNA vaccine from Pfizer and BioNTech may be less effective than Moderna's against the Delta variant of the coronavirus, according to two reports posted on medRxiv on Sunday ahead of peer review

Bayer, on Thursday 5 august, boosted its drug pipeline with a $2 billion takeover and lifted its outlook for 2021 after sales of prescription medicines recovered from restrictions related to the COVID-19 pandemic.

Sanofi said, on Tuesday 2 august, it has made a $3.2 billion offer to buy U.S. biotech company Translate Bio, as it bets on next-generation mRNA technology after setbacks in the COVID-19 vaccine race, confirming a Reuters exclusive report.

GSK forecast 2021 earnings at the better end of its guidance range on Wednesday, buoyed by a recovery in routine visits to doctors and sales of its COVID-19 vaccine booster that helped the drugmaker beat second-quarter profit expectations.

BioNTech wants to build on its success in COVID-19 by developing the first vaccine for malaria based on mRNA technology and aims to start clinical testing by the end on 2022, in an attempt to eradicate the mosquito-borne illness.....

The European Centre for Disease Prevention and Control has designated Lambda a "variant under monitoring", and Public Health England regards it as a "variant under investigation"....

Swiss contract drugmaker Lonza lifted its 2021 outlook on Friday after sales for the first half of the year beat analyst expectations as it benefits from a booming business making ingredients for COVID-19 vaccines...

The Delta variant of the coronavirus is the cause of more than 80% of new U.S. COVID-19 cases, but the authorized vaccines remain more than 90% effective in preventing hospitalizations and deaths, said top U.S. infectious disease expert Anthony Fauci during U.S. Senate hearing on Tuesday 19 July...

Italy's Stevanato Group S.p.A. made a tepid debut on the New York Stock Exchange as its shares slid, giving the world's second largest glass vial maker a valuation of $5 billion.

Even so, plans to give people a third shot have been unveiled by the UK's Joint Committee on Vaccination and Immunisation (JCVI). The two main arguments to support giving a third dose are that the effectiveness of the first two jabs falls over time, and that there's a need to take new vaccines to deal with viral variants, such as the delta variant. But what does the evidence say?

Pfizer Inc's push for health regulators to authorize a third dose of its COVID-19 shot is not yet backed by evidence, despite the fast-spreading Delta variant, vaccine experts said....

6 questions answered on how to stay protected...

Why, doesRecipharm, has signed an MOU (Memorandum of Understanding), along with His Majesty the King of Morocco, Mohammed VI, the Moroccan Government and a consortium of the country's leading banks, that will see the company operate a new fill finish factory in Morocco...

Why, does France still not have on its territory a great leader in innovation in health? The pandemic that the world has been facing for more than a year has shown the importance of merging innovation and healthcare. While France has not been able to bring a vaccine candidate against Covid-19 to the market, the French government wants to trigger major improvements in the health system. It also aims to create a powerful HealthTech sector...

South Korea is in talks with mRNA vaccine makers including Pfizer and Moderna to produce COVID-19 shots in the country and is ready to offer the capacity to make up to 1 billion doses immediately, a senior government official said

While several countries introduce tighter Covid-19 rules to slow down the number of cases and deaths due to variants among their populations, governments are also getting ready to fight against the virus for the coming months and even years...

Five Indian generic drugmakers, including Cipla and Dr Reddy's Laboratories, said on Tuesday they would jointly conduct a clinical trial in India for Merck & Co' s experimental anti-viral drug to treat mild COVID-19 in non-hospitalised patients

A French and European law perspective on how fundamental rights are challenged...

The latest setback for Johnson & Johnson's COVID-19 vaccine was the U.S. Food and Drug Administration's order on June 11, 2021, to discard 60 million doses that failed to meet quality and safety guidelines. A Baltimore manufacturing facility run by Emergent BioSolutions had been producing COVID-19 vaccines for both J&J and AstraZeneca and inadvertently mixed up ingredients from the two companies.

June 23, all eyes were on GlaxoSmithKline's chief executive Emma Walmsley, as she detailed the group's prospects after her planned restructuring. She confirmed the split between the huge consumer arm and the focused drug and vaccines company - "New GSK". Planned demerger confirmed mid-2022 will create new world leader in consumer healthcare. The new Consumer Healthcare company will have a portfolio which generated annual sales of more than £10 billion in 2020

Medical equipment maker Danaher Corp announced on June 17 that it would buy privately-held biotech company Aldevron in an all-cash deal for around $ 9.6 billion.

Data from clinical trials of three experimental Alzheimer's disease drugs expected to start emerging next year could help shed light on whether US regulators were justified in their controversial approval of Biogen Inc's aducanumab treatment, without clear evidence that it works.

While the word "counterfeit" may conjure up images of fake cash and knock-off handbags, the pharmaceutical industry - and with it, the fight against COVID-19 - has been significantly affected by illicit goods.

What was the impact of COVID-19 pandemic on cancer care? It was (and is still) "substantial" according to the latest Iqvia report on "2021 Global trends in cancer". When asked about their perceptions of their patients' experiences during Covid-19, as of February 2021, almost 60% of US oncologists reported that their patients were experiencing financial hardships and logistical challenges with the new ways of working.

The globalisation of the market, the grow ing number of players and high innovation pressure have signific antly increased what is demanded of companies in the healthcare and life science market. To cope with these demands, numerous companies are turning to partnerships, especially during the current pandemic, in order to combine their strengths, know-how and resources with a partner.

In spite of the COVID-19 pandemic, developments in cancer treatment continued "to be the most impactful clinically and most numerous of all the areas in life sciences research, catching over 30 % of new medicines", an IQVIA report stated. Global spending on oncology drugs reached $164 billion in 2020, increasing at an average 14.3% over the past five years. It should exceed $260 billion by 2025, with growth slowing to 9-12% from biosimilar savings. Immuno-oncology would represent 20% of global oncology spending by 2025.

Under the coordination of Cécile Théard-Jallu, Partner at De Gaulle Fleurance & Associés and Alison Choy Flannigan, Partner at Hall and Wilcox, respectively acting as its Vice-Chair and Newsletter Officer, the Healthcare and Life Sciences Committee of the International Bar Association (IBA) has collected a series of twenty articles dealing with these issues around COVID-19 and vaccines, written by leading health and life sciences lawyers from across Europe, Central and South America and the Asia Pacific region.... ...

Germany plans to pay vaccine manufacturers an annual reservation fee to build up reserve capacity of around 600-700 million doses per year to help it fight future pandemics, Health Minister Jens Spahn said...

Increased protectionism or "back to normal" strategy against COVID-19? May 25, the FDA announced having updated its guidance to review Emergency Use Authorization for Vaccines to prevent Covid-19. It decided to include a new section in its guidance first released last February 2021, in order to clarify its position....

While the focus has been largely on vaccines, you might have also heard Pfizer is trialling a pill to treat COVID-19. It almost sounds too good to be true. Indeed, the results are very preliminary - but it's a promising approach. ...

In 2020, the COVID-19 pandemic almost stopped life all over the world. But it did not interrupt the cycle of R&D in life sciences. Activities largely continued, with vaccines being developed in an average of 7 months compared to 9 years and 4 months for other vaccines. According to the latest Iqvia report (1) "the life sciences innovation system - including hundreds of companies, governments, researchers, doctors, and nurses - adapted to the COVID-19 pandemic in ways large and small". Let's discover what the main trends of 2020 were, which are likely to go on throughout 2021...

Dr. Anthony Fauci, the nation's top infectious disease official, said he and many experts felt it was more likely that COVID-19 was a "natural occurrence" but couldn't know the origin for sure, and called for further investigation.

Viruses are constantly changing. This is because errors sometimes occur when they copy their genetic material. Some errors have no effect at all. Some might make the virus less viable. Some make it more benign, which means it can survive but doesn't cause disease. The errors to watch for are those that might make the virus more infectious, or better able to avoid the immune system that is trying to counter them, either driven by natural infection or stimulated by a vaccine.

More than one year in the pandemic, where do pharmaceutical markets stand? What are the main consequences of two or even three waves of infections and lockdowns, on clinical trials, healthcare systems, pharmaceutical sales? Last but not least, what are the recovery forecast as vaccination campaigns are being rolled out in a growing number of countries?

Sandoz, a division of Novartis, is strengthening its European antibiotic manufacturing network by increasing production capacities in Kundl, Austria and Palafolls, Spain. As part of this network modernization plan, Sandoz will phase out the current production of oral APIs at the Franqueses site in Spain, which it plans to close in 2024.

A second-generation COVID-19 vaccine developed by CureVac and GlaxoSmithKline, designed to protect against coronavirus variants, produced a high level of immune response in a trial in rats, the companies said on Thursday, 17 May.

A new global system should be set up to respond faster to disease outbreaks to help ensure no future virus causes a pandemic as devastating as COVID-19, an independent World Health Organization review panel said on 12 May.

When the Covid-19 pandemic shakes companies' financial results, some are boosted whereas others are weakened. With most companies having released their 2021 Q1 results, the picture looks mixed: governments prioritization of Covid-19 vaccinations over those to prevent other illnesses have mainly supported companies involved in fighting against the pandemic by all means

The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

This marks a step closer for China to have localized manufacturing capability for the German firm's vaccine. Five domestically-developed COVID-19 vaccines are being used in the country, while no foreign ones have gained regulatory approval

President Joe Biden on Wednesday threw his support behind waiving intellectual property rights for COVID-19 vaccines, bowing to mounting pressure from Democratic lawmakers and more than 100 other countries, but angering pharmaceutical companies...

COVID-19 vaccines are key to ending the pandemic. From a humanitarian, moral and pragmatic perspective, the countries must unite to ensure fair and rapid access to these vaccines, worldwide. As political and health leaders have stressed: no one is safe until we are all safe....

Demand for the Pfizer-BioNTech COVID-19 vaccine is so strong that Pfizer expects the product to make up more than one-third of this year's total companywide sales after quarterly results beat and it raised full-year guidance...

According to the World Health Organization, there are 277 Covid-19 vaccines in devel-opment globally, of which 93 have entered human testing. Most of the projects in clini-cal testing are injected (78 projects representing 84 %). There are also two oral formu-lations (2 %) and seven nasal-spray formulations (8 %)...

The global active pharmaceutical ingredients market is projected to reach USD 248.3 billion by 2025 from USD 187.3 billion in 2020, at a CAGR of 5.8% during the forecast period...

The U.S. government agreed to increase Moderna's COVID-19 vaccine contract from $ 236 million to approximately $ 1.25 billion, to include additional costs related to vaccine studies. ....

Drugmaker Lonza Group, under pressure to find workers to help speed production of Moderna Inc's COVID-19 vaccine, is recruiting temporary employees from food giant Nestle to staff Swiss plants making ingredients for the shot....

Surges of new coronavirus infections blow up in various countries including India, Russia or even Japan. But Moderna's CEO, Stephane Bancel considers that the world may face a potential surplus next year in capacity...

It was 7:30 a.m. on Christmas Eve when Cha Jung-hoon, South Korea's deputy minister for small businesses, got a call from his boss to make an urgent three-hour car trip to visit syringe maker Poonglim Pharmatech...

The European Medicines Agency (EMA) said on Tuesday (April 20) the benefits of inoculating the Johnson & Johnson's COVID-19 vaccine outweighed the risk of developing blood clots, after it found a link between the vaccine and rare occurrences of the side effect.

In the first three months of 2021, 15 new drugs were approved by the FDA. This result beats the 12 approvals recorded last year and far exceeds the 7 approvals in Q1 2019. Nevertheless none of the most-anticipated drug approvals in 2021 occurred during the period.

While many countries are still fighting against the pandemic and struggling to fight vaccine doses to immunize their citizens, the harmlessness of some of the available vaccines, e.g. AstraZeneca and Janssen, is now more acutely debated due to side effects, more particularly thrombosis cases, having appeared, affecting certain segments of the population.

Thermo Fisher Scientific Inc. is nearing a deal to buy pharmaceutical testing company PPD Inc. for more than $15 billion.

With more than 133.9 million people around the world diagnosed with Covid-19 on April 8, and more than 2.9 million people dead, vaccination campaigns definitely are the main barrier against the pandemic. According to study findings published in the NEJM (New England Journal of Medicine), Moderna's vaccine mRNA-1273 appears to offer protection against Covid-19 for at least six months. Meanwhile, Pfizer and BioNTech's, BNT162b2, is said to be 91.3% effective at preventing the disease.

Follows reports over recent weeks of blood clots in a small number of people around the world who had received the AstraZeneca vaccine. Scientists have termed the condition "vaccine induced prothrombotic immune thrombocytopenia" (VIPIT). But what does this actually mean, how significant is the risk?

Will worldwide Covid-19 deaths decrease one day? According to a Reuters tally, they are rising once again, especially in Brazil and India, crossing 3 million on April 6. As it took more than a year for the global coronavirus death toll to reach 2 million, the additional 1 million deaths occurred in about three months, in spite of vaccination efforts across the globe.

A day full of news for the two german manufacturers of anti-covid vaccines. On March 30, the two companies involved in developing a messenger RNA vaccine against Covid-19 announced important milestones. BioNTech and partner Pfizer indicated it expected to expand manufacturing capacity to up to 2.5 billion doses by end of 2021, with signed orders for 1.4 billion doses of its vaccine to date for delivery in 2021. Meanwhile CureVac disclosed it was organizing the manufacturing production of its CVnCoV vaccine candidate.

After Japan, France and the EU, now the Australian view:
"Liability issues with COVID-19 and COVID-19 vaccines - who should be responsible for adverse events?"

Moderna Inc, Pfizer and BioNtech are not the only companies to use messenger RNA (mRNA) in their vaccines projects. Several drug manufacturers are also working hard on this technology to develop treatments and vaccines for various diseases.

Last year, much of Europe's leaders watched with dismay as the UK and US governments struggled to deal with the pandemic. The roles quickly changed, with the UK now administering over 40 doses of vaccine per 100 people and the US over 34 doses per 100 people. Within two days, last week, the United States succeeded in vaccinating 6 million people! The European Union administered a first dose to 10.4% of the population only on March 19, 2021 and 4.5% of the population received two doses of the vaccine. ...

Collectively, we did not see it coming on such a scale. The Covid-19 pandemic has exposed weaknesses in global pharmaceutical supply chains— in particular the dependence on Active Pharmaceutical ingredients (APIs) outsourced to Asia — and governments have responded forcefully with production relocation initiatives. Is this really a structural change or simply a short-term emotion? ...

With vaccination now well underway in every part of the world, it becomes more and more obvious that vaccine hesitancy is slowing down, whereas the need of millions of jabs is increasing...

With the FDA's authorization, end of February, for the use of the Johnson & Johnson coronavirus vaccine in adults, the world scientific community now has four different vaccines at its disposal to fight the pandemic.

Joe Biden has retained Donald Trump's idea: he relies in part on drugstore and supermarket chains to administer millions of covid-19 vaccinations to Americans

With 53 drugs approved by the FDA, 2020 was very dynamic in terms of new approvals in spite of the sanitary crisis and the economic lockdown. But in the end, which products have taken the lead and reached the most sales?

The values of public CDMO shares continued to outperform in 2020, with growth for the best between 70 and over 90% (Lonza, West Pharma and Catalent).

How did major companies manage their businesses in 2020, amid Covid-19 pandemic, economic lockdowns and above all, "ups and downs" in R&D to bring to the market vaccines candidates against the virus?
PHARMAnetwork reviews the Top 5 pharmaceutical companies' 2020 financial results and 2021 forecasts.

The global market demand for anti-Covid vaccines is much higher than the current production capacities of Western countries. This demand could last for several years depending on several factors such as the duration of the effectiveness of vaccine immunization, the arrival of new variants leading to new vaccination campaigns, etc.

Year-to-date tally at the European Medicines Agency (EMA) suggests the trend for new drug approvals in 2020 hasn't suffered from the Covid-19 pandemic. At the end of the 11 Committee for Medicinal Products for Human Use (CHMP) meetings, some 96 new medicines were approved in Europe throughout the year.

As Commissioner Stephen Hahn will depart the FDA by January 20, when the Biden administration takes office, review of drug approvals in 2020 shows the Covid-19 pandemic did not slow the trend. According to the FDA, the Center for Drug Evaluation and Research approved 53 "first-of-their-kind medicines" for the US market....

While Pfizer/BioNTech's Covid-19 vaccine candidate gained emergency use authorization in the UK on December 2, making it the first in Europe to get the green light, what happened in the rest of the pharma-industry? Many things for sure, as all companies are not exclusively working on vaccines.

The European Health Union is on track; mid-November European Commission president, Ursula von der Leyen offered a €5 billion budget dedicated to health over the next seven years...

The R&D on Covid-19 vaccines and treatments is not the only goal of Big Pharma. Interest in gene therapy development remains very high, as evidenced by several recent deals and agreements.

Will aducanumab become one day the first medication approved for Alzheimer? What happened last week confirms if needed that the story has not been written yet and that the cycle failure is not over...

Were the Top 10 best-selling pharmaceutical drugs in the world impacted by social distancing measures, delays in elective surgeries, prioritization of Covid-19 patients during the first nine months of 2020? As most drugmakers have just announced their third quarter results, it is clear that Big Pharma's resilience is a reality, while blockbusters still make their way...

The annual meeting of the European Society of Medical Oncology (ESMO) took place virtually this year, due to the Covid-19 pandemic. New treatment options were presented, new results were unveiled that could accelerate future adoption of medicines.

February 3, Jazz Pharmaceuticals agreed to pen a deal worth up to $7.2 billion for cannabinoid GW Pharmaceuticals, whose epilepsy med Epidiolex could become a blockbuster in sales.

NextPharma, CDMO specializing in finished oral and topical dosage forms (including sterile ophthalmics), acquires the industrial sites of Ploermel (FR) and Edinburgh (UK) from Lonza...

AstraZeneca's $39 billion acquisition of Alexion strengthens several assumptions: firstly, rare-disease segment is more and more becoming a key issue for big and small pharmaceutical companies; secondly mega-deals are not over (it is the largest deal in AstraZeneca's history). And thirdly, there is still future for the pharmaceutical industry outside Covid-19 R&D.

EQT IX, through Roar BidCo AB, announced a public offering of SEK 220 in cash per share to the shareholders of Recipharm AB and SEK 1,427,010 per Recipharm convertible bond with a par value of 1 000,000 SEK.