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Gilead CEO Daniel O'Day (Credit: Georgios Kefalas/AP)

HHS is tak­ing Gilead to court, seek­ing dam­ages for in­fring­ing gov­ern­ment HIV patents

Gilead earlier this year fired an opening salvo by marching to the US Patent and Trademark Office and requesting a review of the validity of the patents for HIV preventative treatment or PrEP (pre-exposure prophylaxis) granted to the HHS since 2015.  On Wednesday, the tactic blew up as the US government retorted by filing a patent infringement lawsuit against the California drugmaker.

The suit, filed on behalf of the HHS, alleges that Gilead deliberately violated CDC’s patents, and profited from research funded by million’s of taxpayer dollars and has reaped billions from the sale of its therapies — Truvada and Descovy — as PrEP treatments. The HHS has also claimed that the US drugmaker repeatedly refused to license the patents.

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On the heels of a $6.9B As­traZeneca pact, IP dis­pute be­tween Dai­ichi Sankyo and Seat­tle Ge­net­ics rips open in law­suit

A long-running collaboration on ADC tech with Seattle Genetics that ended 4 years ago has come back to haunt Daiichi Sankyo.

Seven months after AstraZeneca stepped up with a record-setting $6.9 billion deal to license a highly promising cancer drug that appears poised for a near-term approval, Daiichi Sankyo has called up the legal troops to fight back in court against Seattle Genetics’ claim to their IP, stemming from their tech alliance.

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Is FDA do­ing enough to bring biosim­i­lars to mar­ket? Ex­perts dis­cuss

As the number of biosimilar approvals continues to rise in the US, the number of biosimilar launches continues to lag, but experts explained how this is more of a legal issue than a problem with the FDA.

Chad Landmon, partner at Axinn, Veltrop & Harkrider LLP, offered an overview on Monday at the Association of Accessible Medicines’ conference in Bethesda, MD, of the biosimilar “patent dance,” which is the convoluted and often uncertain process by which the patent issues are resolved ahead of a biosimilar’s launch.

As­traZeneca wins ku­dos for pipeline turn­around in a new rank­ing of the top 10 R&D play­ers in the bio­phar­ma world

Two years ago, after the first leg of AstraZeneca’s highly touted MYSTIC study failed, with Imfinzi and tremelimumab flunking a major test in lung cancer, the pharma giant’s R&D group looked like they were about to be put on life support. Today, they’re being hailed as the most innovative and inventive major player in drug development today.

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Worth­less? Short at­tack on Fi­bro­Gen claims their ane­mia drug roxa has a lethal Achilles’ heel — and it’s go­ing down

Usually a short attack takes months to play out. For Aaron Wedlund’s latest all-out assault, we’ll likely know pretty much whether he’s right or wrong about a looming biotech stock disaster in 4 days.

That’s the deadline for FibroGen and AstraZeneca — the big US licensee — to get into the details on their pooled safety analysis of roxadustat, an anemia drug that has been a central focus for investors for years now. Positive efficacy data have been rewarded with a $3.5 billion market cap.

Wedlund, who handled Sahm Adrangi’s short thesis biotech analyses at Kerrisdale for a number of years before going off on his own, is betting that roxadustat will be revealed as a clear loser when researchers unveil the hard numbers on the pivotal safety data on major cardio events, or MACE, compared to placebo and EPO.

“Essentially,” he tells me, “if the MACE is higher (on roxa) then this drug is dead.” And up to now he claims the sponsors have only been able to manage concerns about safety by manipulating the results — which regulators won’t approve of.

First, some background.

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Stephen Hahn, AACR

Right on dead­line, Trump taps Stephen Hahn as new FDA com­mish. Now what?

Stephen Hahn’s nomination as the new commissioner of the FDA was delivered right on schedule Friday, with the clock ticking down on the November 1 deadline President Donald Trump faced in finding a permanent replacement for Scott Gottlieb. The pending news had become the worst kept secret in Washington. But the full meaning of the move is still undetermined.

The Chief Medical Executive at MD Anderson had a rep for steering straight into confrontation, when the future of the institution was at stake. More problematic, perhaps, will be his role in dismissing Chinese researchers at a time the Trump administration has been bearing down on the Asian giant. Just how Hahn will manage drug development, which is my primary arena of interest, is going to take some time to figure out.

Eight years af­ter a land­mark buy­out, Sanofi agrees to pay ag­griev­ed Gen­zyme share­hold­ers $315M to set­tle foot-drag­ging claims

Sanofi’s $20 billion deal to buy Genzyme in early 2011 qualifies as one of the smartest M&A pacts in industry history, netting a blockbuster MS drug franchise that still delivers billions to the pharma giant.

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Boris Johnson and Jeremy Corbyn [Images: AP Images, Illustration: Endpoints News]

UK's John­son, Cor­byn bick­er over US trade and Ver­tex deal

As another UK election beckons, prime minister Boris Johnson and opposition leader Jeremy Corbyn engaged in yet another dustup about the state of the National Health Service (NHS) in the last round of Prime Minister’s Questions presided by legendary outgoing speaker John Bercow.

Corbyn accused Johnson and his government of conducting ‘secret meetings’ with US pharmaceutical executives as part of a post-Brexit trade deal, citing reports including Channel 4 dispatches that reported on Tuesday that the price the NHS pays for US medicines could soar under a future trade deal.

Cat­a­lyst Phar­ma's Fir­dapse bet on con­gen­i­tal myas­thenic syn­dromes turns sour

Months after Firdapse maker Catalyst Pharmaceuticals filed a lawsuit against the FDA, the Florida company on Wednesday said the drug had failed a pivotal trial in patients afflicted with congenital myasthenic syndromes (CMS), an umbrella term for rare neuromuscular disorders comprising a spectrum of more than 50 genetic defects.

The drug, known chemically as amifampridine, was sanctioned for use in adult Lambert-Eaton myasthenic syndrome (LEMS) patients in November 2018. The company is working on expanding the label to include patients with CMS, MuSK-positive myasthenia gravis (MuSK-MG) and spinal muscular atrophy (SMA).

Photo: AP Images

No­var­tis takes a hit as FDA or­ders a hold on Zol­gens­ma tri­als in wake of fresh safe­ty con­cerns

The FDA has ordered Novartis to halt enrollment and dosing in a set of trials for Zolgensma, their gene therapy for lethal cases of spinal muscular atrophy. And the latest setback triggered a frenzy of analyst notes as they sized up who among Novartis’ rivals in the field would benefit most.

The hold was implemented after Novartis’ subsidiary AveXis — still operating under the glare of an FDA investigation into an ethics scandal — informed regulators about concerns raised by an animal study pointing to “dorsal root ganglia (DRG) mononuclear cell inflammation, sometimes accompanied by neuronal cell body degeneration or loss.”

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