BioNTech and Pfizer are facing another lawsuit claiming that their Comirnaty-branded Covid-19 vaccine infringes another company’s patent. The latest to sue is US rival Moderna, which claims the German-American duo copied the original mRNA technology it used for its first-generation shot Spikevax.
Pfizer is paying $5.4 billion to acquire Global Blood Therapeutics (GBT), a drugmaker specialized in treating blood disorders. It is one of several deals the company has inked recently to offset dwindling sales from its vaccine and therapeutics for Covid-19.
Pfizer and BioNTech are fighting back against CureVac’s lawsuit that asserts the makers of the Comirnaty-branded mRNA vaccine for Covid-19 infringed its patent.
The Jul.18 launch of GSK’s consumer healthcare spinoff Haleon on the London Stock Exchange – said to be the largest London listing in more than a decade – seems to have gone off more like a whimper than a bang.
Pfizer and BioNTech have filed an application with the European Medicines Agency (EMA) for approval of the Comirnaty Covid-19 vaccine in children aged six months to five years.
Two globally oriented drugmakers, Pfizer and Sanofi, are making moves that some may interpret as attempts to allay the pharma industry‘s reputation for being “only in it for the money” but could potentially benefit poorer countries if all goes to plan.
Sanofi and GSK are touting their latecomer protein-based Covid-19 vaccine as a potential game changer in the fight against the Omicron variant.
Pfizer is to invest $95 million and take an equity share of 8.1% in in Valneva in order to further support development of a vaccine for Lyme disease.
Pfizer will invest $120 million at its plant in Kalamazoo, Michigan, to support US production of its Paxlovid (nirmatrelvir) oral antiviral treatment for Covid-19. The company said the money will fund an expansion of the active pharmaceutical ingredients (APIs) and registered starting materials (RSMs) used to produce the treatment and make it one of the world’s largest producers of APIs.
Pfizer is set to start divesting its 32% stake in Haleon, the consumer health joint venture with GSK, when the British pharma completes the company’s spinoff and Haleon begins trading on the London Stock Exchange on July 18.
Somewhat later than expected, the US may soon be able to offer Covid-19 vaccinations for children five years of age and younger, something parents have repeatedly demanded. And there may be two companies’ mRNA-based shots to choose from.
Major drugmaker Pfizer has agreed to buy US biotech Biohaven Pharmaceutical for around $11.6 billion. Founded in 2013 and based in New Haven, Connecticut, Biohaven specializes in drugs that target neurological diseases and rare disorders.
Pfizer has agreed to buy privately held, clinical-stage biopharma ReViral for up to $525 million, including upfront and development milestones. ReViral is focused on developing and commercializing novel antiviral therapies that target respiratory syncytial virus (RSV), which can lead to severe and life-threatening lower respiratory infections in high-risk populations.
The US Food and Drug Administration has scheduled a virtual meeting of its scientific advisory panel for Apr. 6 to discuss the prospect of future Covid-19 boosters and the process for updating existing vaccines. The US Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) will participate.
Pfizer and BioNTech have submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose of their Comirnaty vaccine for adults 65 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.
Under order from a US federal judge in Texas, the US Food and Drug Administration (FDA) on Mar. 1 began publishing information relating to Pfizer’s application for approval of the Covid-19 vaccine it developed together with Germany’s BioNTech.
US healthcare giant Johnson & Johnson and three major distributors, AmerisourceBergen, Cardinal Health and McKesson, have finalized a long-negotiated nationwide settlement linked to their responsibility for the opioid addiction crisis.
With Covid-19 vaccine distribution in poor countries showing no signs of improvement, Anglo-Swedish drugmaker AstraZeneca and the Covax vaccine sharing program have come fire. The relatively short shelf-life of the pharma group’s viral vector-based shot Vaxzevria in particular is complicating the worldwide rollout, Reuters reports, citing World Health Organization (WHO) documents.
A vaccine to protect children under the age of five against Covid-19 won’t be on the market soon, it seems. Pfizer/BioNtech, the only vaccine maker with near-term plans to launch a children’s vaccine, will not accelerate its application with the US Food and Drug Administration (FDA) for an emergency use authorization (EUA) as some had hoped. Both companies and the health agency now agree that more time is needed.
Pfizer and BioNTech are poised to begin their first clinical trial with a new vaccine candidate adapted to offer protection against the Omicron variant of the coronavirus. The study with 1,420 healthy adults aged 18 through 55 that will include some of the participants from the companies’ Phase 3 booster study is aimed at determining the potential need for variant-based vaccines.
Pfizer and BioNTech expect to have a modified version of their mRNA-based Covid-19 vaccine ready to tackle the Omicron variant by March, Pfizer CEO Albert Bourla said on Jan. 10. The partners already have begun manufacturing trial doses at their own risk, he said, but did not disclose where they will be sold, only that the doses will be available for countries that need them quickly.
Between the Christmas and the New Year’s bells and on both sides, the international pharmaceutical and healthcare sector continued battling the coronavirus pandemic. In one of the most watched developments – most of which took place in the US – Novavax finally fulfilled its pledge to file final data to the US Food and Drug Administration (FDA) for Emergency Use Authorization of its protein-based Covid-19 vaccine during the year’s fourth quarter.
With the fast rolling wave of yet another Coronavirus variant sparking global concern, vaccine mandates, booster shots and efficacy studies are dominating headlines in the run-up to the year’s end, sidelining chemical companies’ news of progress toward net zero emissions two or three decades down the road. Worries are increasing that millions of people not only have not yet been vaccinated or that some of the vaccines are not protective enough.
As the most recently documented Covid-19 variant, Omicron, continues to rapidly circle the globe – it has now been found in 57 countries and 21 US states, according to the US Centers for Disease Control – Pfizer and BioNTech have become the first vaccine manufacturers to claim that their booster shot can deal with it.
With a vote of 13 to 10, the Antimicrobial Drugs Advisory Committee, an advisory panel to the US Food and Drug Administration, narrowly decided to to recommend emergency use authorization (EUA) of the Covid-19 antiviral pill molnupiravir (brand name Lagevrio) developed by US drugmaker by Merck &Co together with compatriot Ridgeback Biotherapeutics.
Britain’s largest drugmaker, GlaxoSmithKline (GSK) has landed a major coup, luring Pfizer’s vaccines R&D chief away, as it tries to regain its position in the top tier of the vaccine league and build up its presence in the mRNA field. On Dec. 3, Philip Dormitzer, who had served as the US pharma giant’s chief scientific officer for RNA and viral vaccines since 2015, will say goodbye to New York and, figuratively, at least, hello to London.
In response to new data published by rival Merck that downgrade earlier efficacy forecasts for its for Covid-19 oral antiviral treatment, Pfizer has announced will increase production capacity of its own antiviral pill Paxlovid as it waits for an emergency use authorization (EUA) from the FDA.
Days before news of the omicron-dubbed latest coronavirus mutant emerged, the administration of US president Joe Biden called on the courts to remove a stay on the implementation of its plans to mandate Covid-19 vaccines mandatory for employees of all companies employing more than 100 people by Jan. 4, 2022 or require them to undergo weekly testing.
Pharma giant Pfizer has filed an application with the US Food and Drug Administration seeking an Emergency Use Authorization (EUA) for its Paxlovid-branded antiviral oral CovidD-19 treatment. Specifically, the company is seeking authorization for the oral drug to be used in treating mild to moderate disease in patients at a higher risk of hospitalization and death.
Pfizer and BioNTech are expected to seek an Emergency Use Authorization (EUA) for their Covid-19-vaccine booster shot to be given to anyone 18 and older, an unnamed US official told journalists on Nov. 8, confirming a report by the newspaper Washington Post. The request could be made as early as this week, reports said.
Novavax has completed the submission of real time data to the UK’s Medicines and Health Regulatory Authority for the authorization of its Covid-19 vaccine candidate. It would be the first protein-based shot to be approved by the British drugs regulator.
In a decision not everyone anticipated, the EU’s drugs regulator, European Medicines Agency, EMA, announced on Oct. 4 it was authorizing a booster shot of the Pfizer/BioNTech and Moderna Covid-19 vaccines for healthy adults, to be given at least six months after the second dose.
Acting quickly after its advisory panel published its guidance, the US Food and Drug Administration (FDA) on Sept. 22 announced it was amending its Emergency Use Authorization (EUA) for Pfizer/BioNTech’s Covid-19 vaccine to allow a booster dose to be administered at least six months after completion of the primary series.
The US plans to more than double its commitment to donate Covid-19 vaccines to the developing world, President Joe Biden announced on Sept. 22 at a virtual vaccine summit he organized on the sidelines of the United Nations September general assembly.
Phase 2/3 clinical trials with the Pfizer/BioNTech Covid-19 vaccine Comirnaty have shown that it is safe, well tolerated and produces robust neutralizing antibody responses in children aged 5 to 11 years, the companies said on Sept. 20. The vaccine partners now plan to submit the data to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies around the world “as soon as possible.”
