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.