Pharma channel feed

Janet Woodcock, director of the Center for Drug Evaluation and Research (AP Images)

Gov­ern­ment gears for un­prece­dent­ed chal­lenge of Eli Lil­ly an­ti­body roll­out as ef­fi­ca­cy ques­tions linger

After months of anticipation, the FDA has authorized the first antibody treatment for Covid-19. Now what?

The US government faces a challenge unlike virtually any it has faced during or before the pandemic. They will have to distribute scarce quantities of a much-sought drug throughout the country at a time when cases are reaching record levels, overburdening hospitals to the point where, in North Dakota, Covid-19 positive nurses have been authorized to continue working.

Bris­tol My­ers posts an­oth­er win for their Ote­zla com­peti­tor, this time with PhII da­ta in pso­ri­at­ic arthri­tis

Less than a week after claiming a Phase III victory over Amgen’s Otezla in psoriasis, Bristol Myers Squibb has more positive data out in psoriatic arthritis.

The Phase II readout for the TYK2 contender deucravacitinib (BMS-986165), which BMS announced Monday, showed the experimental drug met its primary endpoint of reducing symptoms by at least 20 percent after 16 weeks. BMS measured two dosage levels for the once-a-day pill, 6 mg and 12 mg, with both outperforming the placebo group.

En­do Phar­ma­ceu­ti­cals chops 560 jobs to re­fo­cus on cel­lulite drug launch

Less than a month after inking a $658 million deal to buy out BioSpecifics Technologies, Endo Pharmaceuticals is shuttering multiple manufacturing sites and cutting 560 jobs to refocus on a drug launch in the spring.

The restructuring will occur in phases over the next few years, Endo $ENDP said Thursday. The Dublin-based biotech will gradually exit manufacturing sites in Irvine, CA and Chestnut Ridge, NY, and API manufacturing and bioequivalence study sites in India through the second half of 2022. Plus, it plans on trimming administrative costs by outsourcing “certain transaction processing activities.”

An elec­tion night bereft of an­swers quells bio­phar­ma's 'worst-case' fears — an­a­lysts

What to make of an election night that gave the country a deluge of nerves and no final answers? Well, if you’re a biotech or a pharma executive or investor, you might decide that you got the best of both worlds, analysts suggested Wednesday morning.

Although results are still quite up in the air as of Wednesday morning, by most forecasts, the presidency remained a tossup, while Republicans appear narrow favorites to maintain control of the Senate and Democrats have maintained control of the House. That’s a recipe for a divided government, one unlikely to pass the kind of drug pricing legislation that has gained traction on both parties, SVB Leerink’s Geoffrey Porges wrote.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Prevail and Alector founder Asa Abeliovich (file photo)

Pre­vail and Alec­tor both claim vic­to­ry in ar­bi­tra­tion over sci­en­tist-CEO, telling di­ver­gent tales of con­fi­den­tial hear­ings

At 7 am Monday, Prevail Therapeutics announced their CEO “decisively” won a year-plus-long arbitration battle over trade secrets with his old company, the neurodegeneration rival Alector. Forty four minutes later, Alector put out a press release saying that the arbitrator found in Alector’s favor and against Prevail’s CEO.

It was the second and perhaps final twist in an unusual case that centered on Asa Abeliovich, a former tenured Columbia professor and neurodegeneration luminary, and the intellectual property inside the two high-profile biotechs he helped launch. Drawing from a confidential decision, each side claimed victory, telling overlapping but distinctly divergent tales of where an arbitrator ruled on a man at the center of both companies.

Small cap im­munother­a­py play­er Zio­pharm faces an ac­tivist at­tack, re­bukes call for board seats

Ziopharm Oncology is attempting to fend off an activist attack.

The Boston-based biotech sent a letter to shareholders Monday urging them to reject the proposals from minority investor WaterMill Asset Management Corp that would replace half the company’s board. Ziopharm’s letter, which was published in full Monday morning, stated that the firm’s proposed three new board members, including WaterMill founder Robert Postma, lack the qualifications to run a public company.

No­vo Nordisk qui­et­ly nabs a rare 'break­through' sta­tus in NASH for its cash cow

Earlier this month, the small French biotech Inventiva touted themselves as having won the first FDA breakthrough designation in NASH since Intercept grabbed the first one back in 2015, before the disease had become one of biotech’s hottest areas. Unbeknownst to them, though, a much larger European rival had already landed the status months prior.

Novo Nordisk, the Danish metabolic giant, disclosed in their Q3 report Friday that back in August, the FDA gave them breakthrough status for semaglutide, their blockbuster diabetes drug, in NASH, or non-alcoholic steatohepatitis. The designation sets Novo up as a leading contender in a new wave of companies developing treatments for a silent and widespread disease that, despite a series of setbacks, is still viewed by many as a huge potential market.

Sanofi teams up with Mer­ck to pair Keytru­da with a next-gen IL-2 can­di­date from the Syn­thorx buy­out

Nearly a year after snapping up a next-gen immuno-oncology candidate in its $2.5 billion Synthorx buyout, Sanofi is joining forces with Merck to pair the drug with blockbuster Keytruda.

The pharmas are planning a Phase II trial of Sanofi’s non-alpha IL-2 candidate THOR-707 in combination or sequenced administration with Keytruda for various cancers. While the companies are keeping mum about the financial terms and targets, they said the trials will be Sanofi-sponsored.

Once re­ject­ed, Kala's dry eye drug now gains en­try to a field where No­var­tis is groom­ing its own block­buster

When the FDA slapped a rejection on Kala Pharma’s dry eye drug last August, the biotech’s execs promised investors that a third Phase III study — they had already started at that point — would reverse their fortune.

Today they made good on that promise, clinching an approval for Eysuvis, an ocular corticosteroid being positioned as a first-line, short term treatment of dry eye disease.

Boasting a technology invented by Bob Langer out of MIT, Eysuvis is a corticosteroid, loteprednol etabonate, delivered by mucus-penetrating particles. It promises to enhance penetration into target tissue on the ocular surface, achieving an effect quicker than systemic corticosteroids and stronger than over-the-counter eye drops.

In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

Update: An earlier version of this article misidentified the jailed Insys CEO. Former CEO John Kapoor was sentenced to 5.5 years in prison in January. Endpoints News regrets the error.

The Justice Department’s years-long battle with Indivior has arrived at a rare place: the jailing of a pharmaceutical executive.

A US district court sentenced long-running Indivior CEO Shaun Thaxter to 6 months in federal prison for his role in company efforts to mislead a major healthcare provider about the safety and abusability of their opioid addiction drug Suboxone, which generated billions in revenue over the last decade. Thaxter joins former Insys CEO John Kapoor as one of the only two executives to face prison time for their roles in the opioid epidemic.