biopharma nl

AI drug-discovery firm lands first partnership

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The deal with Roche subsidiary Genentech is likely not the last for Genesis Therapeutics, which is based on AI research undertaken at Stanford. Such partnerships are potentially lucrative for drug-discovery startups.

Takeda strikes $1B RNAi deal with Arrowhead Pharmaceuticals

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The companies will partner on development and commercialization of ARO-AAT, Arrowhead’s Phase II RNA-interference drug for alpha-1 antitrypsin-associated liver disease, a rare genetic disorder. An analyst wrote that the deal makes sense given Takeda’s position in the AAT-augmentation therapy market.

Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M

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The charges, filed in Philadelphia federal court, allege that Teva conspired with four other generic drug companies to fix prices, rig bids and allocate customers. Teva – which the Justice Department and New York’s state government also sued this month for unrelated allegations – said… Read More »Generic drugmaker Teva indicted in alleged price-fixing conspiracy leading consumers to be overcharged by $350M

J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]

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In an interview, Peter Meath, J.P. Morgan’s co-head of Healthcare and Life Sciences, Middle Market Banking & Specialized Industries, says the Covid-19 pandemic has cast a bright light on the life sciences industry with startups raising venture funding at record levels as the virus has… Read More »J.P. Morgan on the state of life sciences and strategies to fuel innovation [Sponsored]

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

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While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science… Read More »FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

J&J to buy Momenta Pharmaceuticals for $6.5B

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The drugmaker emphasized the full global rights it would acquire to Momenta’s lead asset, nipocalimab, which it is developing for several autoantibody-driven diseases and that in certain indications could have peak sales of more than $1 billion.

Founders’ story: Pleiogenix

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Pleiogenix is a biopharma startup developing treatments for liver diseases as well as Covid-19 and non-alcoholic steatohepatitis (NASH). It recently emerged as the winner of the INVEST Pitch Perfect contest for the biopharma track.

GSK nabs FDA approval for first-in-class multiple myeloma drug

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Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.

Merck, Hanmi sign $870M deal for NASH drug

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Hanmi will retain options for the drug, efinopegdutide, in Korea under the deal, in which Merck is paying the Seoul-based company $10 million upfront and up to $860 for development, regulatory and commercialization milestones.

Pfizer, BioNTech start late-stage study of Covid-19 vaccine

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The companies said they had started a Phase II/III trial BNT162b2. The news comes the day after Moderna announced the launch of its Phase III study and days after Pfizer and BioNTech signed a nearly $2 billion vaccine supply deal with the federal government.

FDA guidance eases some Covid-19 vaccine concerns, but others remain

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Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.

Relay Therapeutics prices IPO at $400M

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The company, whose drug-discovery efforts are focused on protein motion and detection of interactions that occur anywhere on a protein rather than only at active sites, filed to go public last month.

MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron

Bari Kowal, vice president of global clinical operations at Regeneron Pharmaceuticals, gives an update on the clinical trials ongoing to develop drugs to fight Covid-19 and provides insights on how the clinical trials landscape and pharma overall must change in the next episode of MedCity… Read More »MedCity Pivot Podcast: An interview with Bari Kowal, vice president of global clinical operations, Regeneron

Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.

The FDA has 60 days to decide whether or not to accept the application. An analyst wrote that the agency accepting it with a priority or standard review may signal whether the agency is seriously considering approval or has continued reservations about the amyloid beta-targeting… Read More »Biogen, Eisai complete submission of controversial Alzheimer’s drug. The ball is in FDA’s court now.

BARDA, DoD give Regeneron $450M contract for Covid-19 antiviral drug

The contract covers manufacture and supply of the two-antibody drug cocktail REGN-COV2. The company had announced Monday that it entered the drug into three late-stage clinical studies, both as a treatment for existing SARS-CoV-2 infections and a preventive treatment for healthy exposed people.