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Novartis, Biogen trim pipelines; Europe proposes major changes to its pharma laws
Novartis has announced plans to discontinue or license out around 10 percent of its projects in the pipeline to concentrate on its most promising programs in core therapeutic areas. Similarly, Biogen has said it will pause or discontinue at least four studies of experimental drugs to focus on more potentially lucrative options.
The US Food and Drug Administration (FDA) has approved Seres Therapeutics’ live microbiome capsule Vowst to prevent the recurrence of Clostridioides difficile infection (CDI), a potentially fatal bacterial infection. The agency has also granted accelerated approval to Biogen’s Qalsody (tofersen) for treating a rare form of amyotrophic lateral sclerosis (ALS).
In Europe, major changes to pharma laws are on the anvil as the European Commission unveiled a draft of the new, proposed legislation. The Commission has also granted marketing authorization to Johnson & Johnson’s Akeega for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adults with BRCA1/2 mutations. And the European Medicines Agency (EMA) has recommended authorization of GSK’s respiratory syncytial virus (RSV) vaccine — Arexvy — in adults aged 60 and older.
The World Health Organization (WHO) has issued an alert after samples of a batch of India-made cough syrup in the Marshall Islands and Micronesia were found to be contaminated with highly toxic substances — diethylene glycol and ethylene glycol.
The Biden administration has urged a US appeals court to overrule a Texas court order that would ban mifepristone, a widely used abortion pill.
In other regulatory news, FDA has asked Sun Pharma to take corrective action at its manufacturing facility in Mohali, India, before shipping any products to the US. The agency has also issued Form 483s to Ipca Labs formulations plant in India and Alvotech’s troubled plant in Reykjavik, Iceland.
Novartis trims pipeline by 10% after R&D review; Biogen to discontinue four studies
Novartis plans to discontinue or license out around 10 percent of its development projects to concentrate on its most promising programs in core therapeutic areas. The decision was taken following a comprehensive review of R&D programs during Q1 2023, where the Swiss pharma found it had more projects than its peers. Novartis’ pipeline has now been reduced to 136 projects, down 16 from the 152 reported in its Q4 2022 earnings.
Similarly, Biogen has said it will pause or discontinue at least four studies of its experimental drugs to focus on more potentially lucrative options. The biotech will terminate two studies of an experimental neurological drug, and will put on hold or scrap at least two more studies in order to cut costs. Biogen has three launches to come this year. It is awaiting full US approval for Leqembi (its second Alzheimer’s treatment) in July.
FDA okays Seres’ pill to prevent recurrence of deadly C. difficile infections
FDA has approved California-based biotech Seres Therapeutics’ live microbiome capsule — Vowst — to prevent the recurrence of Clostridioides difficile infection (CDI), a potentially fatal bacterial infection. Vowst is the first oral microbiome therapeutic to be approved in the US and consists of a specific type of bacteria purified from the fecal matter of healthy individuals. CDI is caused by the prolonged use of antibiotics that wipe out friendly colon bacteria. Seres and partner Nestlé Health Science are planning to make the drug available in the US by June.
FDA grants accelerated approval to Biogen’s Qalsody for treating rare form of ALS
FDA has granted accelerated approval to Biogen’s Qalsody (tofersen) for treating a rare form of ALS caused by a mutation in the SOD1 gene, making it the first drug targeting a genetic cause of the disease and the fourth ALS drug to be approved by the FDA. Biogen is conducting a late-stage study of Qalsody in patients without symptoms to confirm its clinical benefit. According to the US government, around 2 percent of total ALS patients in the US have the SOD1 gene mutation.
EU to bring major changes to its two decades-old pharma legislation
This week, the European Commission unveiled a draft of its proposed legislation that would overhaul its two decades-old medical laws. The draft features new perks for the industry along with stricter regulatory data protection limits for companies that don’t introduce new drugs across all member states.
While the EU says the new incentives system will improve access to medicines, the draft has triggered a tussle between the drugmakers and the European Commission. And pharma companies have warned they will invest and innovate elsewhere.
Europe approves J&J’s Akeega for mCRPC: The European Commission has granted marketing authorization to Johnson & Johnson’s Akeega for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adults with BRCA1/2 mutations. The authorization marks the first worldwide approval for Akeega, a fixed-dose combo of Zejula and J&J’s androgen-directed Zytiga that is used alongside a corticosteroid.
EMA recommends GSK’s RSV vaccine: EMA has recommended authorization of GSK’s respiratory syncytial virus (RSV) vaccine, known as Arexvy, in adults aged 60 and older. Once approved, Europe would be first off the block to launch an RSV vaccine and GSK would be ahead of rival Pfizer in the race to tap the RSV vaccine market (estimated to cross US$ 10 billion by 2030).
WHO issues alert over contaminated India-made cough syrup in Pacific countries
After a spate of child deaths linked to Indian-made cough syrups in The Gambia and Uzbekistan last year, the World Health Organization (WHO) has issued another alert after a batch of contaminated India-made cough syrup was found in the Marshall Islands and Micronesia.
Samples of the cough syrup, called Guaifenesin TG Syrup, were found to contain high levels of the toxic substances, diethylene glycol and ethylene glycol. The manufacturer of the cough syrup, Punjab-based QP Pharmachem Ltd, said it had exported a batch of over 18,000 bottles to Cambodia, but denied sending the product to the Pacific region.
Sun Pharma’s India site halts supplies to US after receiving FDA’s non-compliance letter
FDA has asked Sun Pharma to take corrective action at its manufacturing facility in Mohali, India, before shipping any products to the US. The agency’s ‘Consent Decree Correspondence/Non-Compliance Letter’ instructs the generics drugmaker to hire an independent current good manufacturing practice expert to conduct batch certifications of drugs made at the plant. The facility was already classified as OAI (Official Action Indicated) by the FDA after an inspection in August 2022.
FDA issues Form 483s to Ipca Lab’s India facility, Alvotech’s troubled Iceland plant
FDA has issued a Form 483 with three observations to Ipca Lab’s formulations manufacturing unit at Piparia (Silvassa). The agency inspected the facility from April 18 to 26.
Earlier this month, FDA rejected Alvotech’s Humira biosimilar – AVT02 – for a second time, citing deficiencies at the drugmaker’s manufacturing plant in Reykjavik, Iceland. Now the agency has issued a Form 483 with eight observations to the same plant.
Biden administration appeals to overrule Texas court’s order on abortion pill
The Biden administration has urged a US appeals court to overrule a Texas court order that would ban mifepristone, a widely-used abortion pill, by suspending the drug’s regulatory approval. Meanwhile, the US Supreme Court has overturned the Texas district court’s ruling to remove the approval of mifepristone. The drug will remain available and approved for safe and effective use. The case will now return to the New Orleans-based 5th US Circuit Court of Appeals, where arguments are scheduled for May 17.
Lilly to sell low blood sugar rescue treatment to Amphastar for up to US$ 1.08 billion
Eli Lilly is selling its nasal powder rescue treatment – Baqsimi – for severe hypoglycemia (low blood sugar) in diabetes patients to California-based Amphastar Pharmaceuticals for a deal valued at up to US$ 1.08 billion. Amphastar will pay Lilly US$ 500 million in cash, plus another US$ 125 million after a year and up to US$ 450 million in sales-based milestones.
BMS CEO to step down: Bristol Myers Squibb CEO Giovanni Caforio will step down on November 1 after an eight-year tenure, and the role will be taken over by chief commercialization officer Chris Boerner.The PharmaCompass Newsletter – Sign Up, Stay Ahead
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