Bristol-Myers Squibb and Celgene have a big problem on their hands.

After the market closed Wednesday, Bristol-Myers’ largest investor, Wellington Management, moved to voice its opposition to the company’s $74 billion mega-merger with Celgene. Some analysts — though not all — immediately flagged the move as a real threat to the deal, raising the risk that a major move like this could stir a widespread rebellion among shareholders.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

ARCH co-founder and managing director Bob Nelsen has a well known yen for the home run swing, betting big on potentially transformative meds and tech and the biotech teams he helps bring together. He thrives and bleeds on the cutting edge. And now Nelsen and the ARCH group have debuted 2 big funds to prove that this is the time for the best of biotech to shine — deadly pandemic be damned.

Two new funds, ARCH Venture Fund X and ARCH Venture Fund X Overage, gathered a combined $1.46 billion. And that’s a record. ARCH Venture Fund IX and ARCH Venture Fund IX Overage closed in 2016 with a combined $1.1 billion. ARCH Venture Fund VIII and ARCH Venture Fund VIII Overage closed in 2014 with a combined $560 million.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

After providing an emergency approval to use malaria drugs against coronavirus with little actual evidence of their efficacy or safety in that setting, the FDA has already proven that it has set aside the gold standard when it comes to the pandemic. And now regulators have spelled out a new approach to speeding development that promises immediate responses in no uncertain terms — promising a program offering the ultimate high-speed pathway to Covid-19 drug approvals.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN

Apart from disrupting biopharma R&D and regulatory timelines, the coronavirus pandemic has inevitably ravaged financial markets and eroded investor risk appetite. Investing in the time of coronavirus feels reckless, but if biotech venture funds are any indication, the time is ripe.

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 77,400+ biopharma pros reading Endpoints daily — and it's free.

SUBSCRIBE SIGN IN