Protocols

Gilead says only Teva can market Truvada generic; Denver narrowly votes to decriminalize “magic mushrooms”

Daniel O’Day

→ Under fire for its pricing policy on its HIV prevention pill Truvada, Gilead $GILD has agreed to allow one generic drugmaker Teva $TEVA to begin selling a copycat version of the drug by September 30, 2020 — about one year ahead of three other companies who have attempted to launch their own versions (Amneal, Aurobindo and Mylan), the US drugmaker indicated in a filing posted on Wednesday. A coalition of AIDS activists — including ACT UP New York, Health GAP, Housing Works, #PrEP4All Collaboration — also disrupted Gilead’s annual general meeting of shareholders on Wednesday, confronting newly crowned chief Daniel O’Day with demands that Gilead stop obstructing access to Truvada.

Peter Staley

“Typically, with only one generic on the market, its price is only set about 20% lower than the brand name drug. Teva can expect to become PrEP4All’s next target if they don’t launch their own patient assistance programs. This sweetheart deal with Teva is likely unconstitutional, as are the deals keeping the other three generics off the market until 2021,” HIV activist and PrEP4All co-founder Peter Staley wrote in a Facebook post.

→ Voters in Denver backed the decriminalization of psilocybin — the psychoactive ingredient in “magic mushrooms” — by a paper-thin margin, preliminary figures by Denver’s Election Division indicate. The initiative effectively decriminalizes the use or possession of psilocybin by people 21 and older but does not legalize it or permit its sale. First outlawed in the 1960s as a recreational drug — recent small studies have shown psilocybin can have a beneficial impact on depression and anxiety. Startups are catching on — in March, a global biotech startup raised $43 million to build their psilocybin-focused pipeline.

Meindert Boysen

→ UK’s NICE has changed its mind on Roche’s MS drug, Ocrevus, agreeing to back its use in England’s National Healthcare Service (NHS) after the Swiss drugmaker agreed to sell the drug (known chemically as ocrelizumab) at a lower price — but the details of the deal will remain confidential. “Our earlier draft guidance acknowledged that ocrelizumab represents an important development in the treatment of a condition for which there is a large unmet need. Unfortunately, we couldn’t recommend it at the price offered at that time because it did not represent a cost-effective use of limited NHS resources,” said Meindert Boysen, director of the Centre for Health Technology Evaluation at NICE. Roche estimates roughly 2,700 people could be eligible for treatment with ocrelizumab in England. 

Francois Lebel

Spectrum Pharmaceuticals $SPPI has picked up platform oncology tech developed at UCLA for $3 million upfront and up to $156 million in biobucks. The license with privately held ImmunGene includes a Phase I antibody-interferon fusion molecule directed against CD20 (Anti–CD20-IFNα) being tested for non-Hodgkin lymphoma. “The FIT platform that we’ve acquired today represents a new class of biotherapeutics which may have the potential to make the administration of an antibody-interferon fusion protein feasible and allows Spectrum to harness this powerful immune activating cytokine,” said Spectrum CMO Francois Lebel.


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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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