Nine new coronavirus cases are tied to the Biogen outbreak — as infections spread to 'close contacts'
Health officials in Massachusetts have identified 13 new presumptive cases of coronavirus, with 9 of them tied to the Biogen meeting at Boston Marriott Long Wharf. And this time they’re underscoring how staffers are spreading the disease outside the immediate group of 175 meeting attendees.
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Bob Nelsen at the Milken Institute Global Conference on April 29, 2019 in Beverly Hills, California. (Photo by Michael Kovac/Getty Images)
ARCH chief Bob Nelsen has $1.5B to prove 2 simple points: ‘We’re in the most innovative time ever’ and investors are staying
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.
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UPDATED: Have a new drug that promises to fight Covid-19? The FDA promises fast action but some developers aren't happy
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.
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Stepping out alongside ARCH's record raise, Flagship adds a $1.1B monster fund of its own
ARCH’s unveiling this morning of 2 new funds bulging with $1.5 billion in cash for biotech startups was just the first round of today’s venture news.
Right on its heels we have another monster fund debuting at Flagship Pioneering, another big venture group known for making huge bets on cutting-edge tech — the kind it brews up in its labs.
And this one weighs in at $1.1 billion, which will operate in tandem with the $1.1 billion in funds Flagship rolled out last year.
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Once furious over Novartis’ data manipulation scandal, the FDA now says it’s nothing they need to take action on
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.
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March 31, 2020 07:21 AM EDTUpdated April 1, 04:19 AM
Covid-19 roundup: GSK, Amgen tailor R&D work to fit the coronavirus age; Doudna's genomics crew launches diagnostic lab
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.
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In a stunning setback, Amarin loses big patent fight over Vascepa IP. And its high-flying stock crashes to earth
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.
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AstraZeneca says its blockbuster Farxiga proved to be a game-changer in CKD — wrapping PhIII early
If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.
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Gilead CEO Dan O'Day offers a detailed explanation on remdesivir access — reassuring analysts that Covid-19 data are coming fast
After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.
In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.
O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.
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Merck scores new advance on tumor-agnostic front as Keytruda beat chemo-based regimens in a type of colorectal cancer
Back in 2017, before the term “tumor agnostic” really took hold among cancer drug developers, Merck became the first to secure such an approval for Keytruda as a second-line treatment for patients characterized by a biomarker — rather than where the cancer started in the body. Now it’s looking to break fresh ground with a new slate of data suggesting the drug’s utility in the frontline setting for colorectal cancer.
