Bayer and Kumquat Biosciences announced today that they have entered into an exclusive worldwide license and collaboration to develop and commercialize Kumquat's KRAS-G12D inhibitor.
In what is being billed as a bipartisan effort to address shortages along the US pharmaceutical supply chain, two senators — one Democrat, one Republican — have introduced legislation that calls for an investigation of the problems and development of a plan to reduce the country’s dependence on imported drugs.
To boost supply of the injectable chemotherapy drug cisplatin – the US is facing a shortage of oncology treatments – the Food and Drug Administration (FDA) will temporarily allow imports of 50-milligram vials from Chinese manufacturer Qilu Pha. Canada’s Apotex would distribute.
Pfizer's oral anti-viral Covid-19 treatment Paxlovid has won full approval from the US Food and Drug Administration (FDA) after Emergency Use Authorization was granted in late 2021.
The market value of US vaccine maker Novavax is gaining momentum again on the back of promising data the company recently provided on its combined Covid and flu vaccine data.
All immediate challenges to the status of abortifacient mifepristone on the US market are on ice for the near future after the Supreme Court on Apr. 21 — without considering the merits of the case — approved a Justice Department request to put temporarily suspend recent rulings by a federal district court and an appeals court.
All changes to the US use of abortifacient mifepristone are now on hold – for three more days – pending a review by Supreme Court Justice Samuel Alito of two complex and differing lower court decision on lawsuits brought by anti-abortion groups.
At the beginning of 2023, the US Food and Drug Administration (FDA) stepped into a political hornet’s nest with its decision to allow retail pharmacies to dispense abortion pills over the counter. It is now fighting the backlash, so far successfully.
Catalent has opened a new commercial-scale cell therapy manufacturing facility at its European center of excellence for cell therapies in Gosselies, Belgium.
As abortion continues to dominate the political discussion in the US and at least half of the 50 states move toward outlawing the procedure in response to last summer’s Supreme Court decision that it is not a constitutional right, conservative and religious groupings are pushing for a ban on sales of the oral abortifacient Mifeprex. (mifepristone).
AstraZeneca (AZ) has announced it is permanently backing away from any plans to sell its Vaxzevria-branded Covid-19 vaccine in the US.
US drugs giant Merck & Co has granted Sinopharm exclusive import and distribution rights to its oral Covid treatment Lagevrio (molnupiravir) in China.
Days before the FDA approved the new bivalent Covid-19 vaccine boosters, Pascal Soriot, CEO of AstraZeneca, offered his own assessment of the need for such.
As had been widely expected, the US Food and Drug Administration (FDA) on Aug. 31 granted emergency use authorizations (EUAs) to the new Covid-19 shots developed by mRNA vaccine makers Pfizer-BioNTech and Moderna.
Australian biopharma CSL said this week it has received all the regulatory clearance required to take over Switzerland’s Vifor. The acquisition announced in December 2021 temporarily stalled in May 2022.
It took longer than expected, but the US Food and Drug Administration (FDA) on July 13 finally granted an Emergency Authorization (EUA) to Nuaxovid, the protein-based sCovid-19 shot developed by Novavax.
The US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have ordered 3.2 million doses of Novavax’s Covid-19 vaccine, even before the protein-based and adjuvanted shot has cleared the US Food and Drug Administration.
In the wake of the US Supreme Court’s recent overturn of Roe v. Wade, a 50-year-old decision by an earlier team of justices that guarantees women the right terminate a pregnancy, attention has turned to the so-called morning-after pill mifepristone – which remains legal for now – and easier access to birth control.
While Europe still deliberates, and municipalities monitor sewage to pinpoint the further spread of coronavirus subvariants, especially those evolving from the omicron variant, the US Food and Drug Administration’s advisory panel has voted 19-2 to recommend that the government’s autumn vaccination program be based on the second generation mRNA vaccines developed by Pfizer/BioNTech and Moderna.
In a vote of 21 in favor with one abstention, the US Food and Drug Administration’s advisory panel has recommended that the FDA approve Novavax’s Covid-19 vaccine Nuaxovid for emergency use. If the health agency agrees, it would be the fourth such shot available in the US, joining the mRNA products of Pfizer/BioNTech and Moderna and the viral vector shot of Johnson & Johnson’s pharma subsidiary Janssen.
The US Food and Drug Administration (FDA) has greenlit GSK’s Priorix-branded GSK’s mumps and rubella vaccine (MMR) for people 12 months and older. It is only the second such shot to be licensed for US distribution in more than 50 years. Merck & Co’s MMR-II vaccine was approved by the FDA for the pediatric application in 1971.
US health authorities are restricting the use of the Johnson & Johnson Covid vaccine somewhat belatedly, citing the rare blood clotting issues that have dogged this vaccine from the start, as well as the AstraZeneca shot.
The US Centers for Disease Control and the Food and Drug Administration have removed the IV antibody treatment sotrovimab made by GlaxoSmithKline (GSK) and Vir Biotechnology from the list of approved drug therapies for Covid-19.
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.
The US Food and Drug Administration (FDA) finally has a new commissioner, after 391 days of interim leadership. In a narrow vote of 50 to 46 on Feb. 15, the Senate confirmed Robert Califf to the top job, which has been vacant since January 2021.
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.
US president Joe Biden has nominated Robert M. Califf to return to the job he once held as commissioner of the Food and Drug Administration (FDA). In a statement, Biden – who had been criticized for not naming a new FDA chief sooner, said Califf “has the experience and expertise to lead FDA during a critical time in our nation’s fight to put an end to the coronavirus pandemic.”
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.
In a 16-2 vote, the US Food and Drug Administration’s advisory panel on Sept. 17 recommended against supporting president Joe Biden’s plans to offer a booster dose of the Pfizer/BioNTech Covid-19 vaccine to everyone over 16 years of age. In the two-pronged decision, the panel said it would recommend a third dose only for those older than 65 and the immunocompromised.
Two key vaccine officials of the US Food and Drug Administration (FDA) plan to quit the agency over the next three months in protest against President Joe Biden’s plan to offer Covid-19 booster shots to all Americans starting this month, even if they only received their second shot five months earlier.
Alex Azar, US Secretary of Health and Human Services (HHS), is rumored to be plotting for the Trump administration to oust FDA Commissioner Stephen Hahn in retaliation for the health agency’s issuing its own guidance for approving a Covd-19 vaccine independently of the White House.
The administration of US president Donald Trump said on Oct. 6 it planned to override the tightening of safety precautions for Covid-19 vaccine proposed by the Food and Drug Administration (FDA) two weeks ago, over fears these could delay approval. Later in the day, it did an unexplained about-turn after the FDA published the guidelines on its own website as part of a briefing for outside vaccine advisers.
US president Donald Trump has said he believes the White House could override the US Food and Drug Administration (FDA) if the national health watchdog goes ahead with mooted plans to toughen standards for approval of a Covid-19 vaccine or an Emergency Use Authorization.
Amid worries in the American public that an unsafe vaccine could be approved by the US Food and Drug Administration just in time for the Nov. 3 election, the FDA reportedly will impose new, tougher, standards for an emergency authorization (EUA) of a coronavirus vaccine.
