After critics lambasted Gilead for grabbing the FDA’s special rare drug status on remdesivir, they’re giving it back

March 25, 2020 03:17 PM EDTUpdated 04:57 PM

John Carroll

After critics lambasted Gilead for grabbing the FDA's special rare drug status on remdesivir, they're giving it back

Two days after Gilead won orphan drug status for remdesivir as a potential treatment for Covid-19, they’re handing it back.

The company was slammed from several sides after Gilead reported that the FDA had come through with the special status, which comes with 7 years of market exclusivity, the waiver of FDA fees and some tax credits as well. Typically, everyone who can get orphan status lands it without much of a fuss, but Democratic presidential candidate Bernie Sanders, Public Citizen and other consumer groups were outraged.

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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)

April 2, 2020 06:00 AM EDTUpdated 09:59 AM

John Carroll

Venture

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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April 3, 2020 09:33 AM EDTUpdated 11:46 AM

John Carroll

Bioregnum

IPOs

UPDATED: A small, obscure biotech just won big with their IPO. In this market. Are you kidding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Aaron Royston, venBio

April 3, 2020 08:35 AM EDTUpdated 08:47 AM

Natalie Grover

In Focus

Venture

Investing in the time of coronavirus: the good, the bad and the hopeful, as biotech VC firms close funds worth $3B

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.

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Alexandria Real Estate Equities

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April 3, 2020 10:43 AM EDTUpdated 11:00 AM

Amber Tong

China

Venture

Lilly Asia Ventures co-leads $100M+ round for Chinese biotech and its late-stage lupus drug

Can a Chinese biotech deliver the first new lupus drug in decades? A high-profile group of VCs are betting on it.

Lilly Asia Ventures and Lake Bleu Capital are the co-headliners for RemeGen’s latest raise, which brought in more than $100 million. Hudson Bay Capital and Vivo Capital — which, like LAV, also invested in a pre-IPO round for Legend Biotech unveiled today — chimed in, as did Janchor Partners and OrbiMed.

April 3, 2020 10:34 AM EDT

Natalie Grover

R&D

GSK's asthma biologic Nucala is one step closer to approval in key chronic rhinosinusitis population

Months after GSK’s Nucala cleared in a pivotal rare blood disorder study, the asthma biologic has scored in a late-stage trial in chronic rhinosinusitis patients with nasal polyps.

The British drugmaker on Friday disclosed data from the SYNAPSE study, which tested Nucala (also known as mepolizumab) against a placebo on top of standard-of-care in more than 400 patients, all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and required surgery due to severe symptoms and bigger polyps.

April 3, 2020 10:30 AM EDT

John Carroll

Deals

R&D

Servier bags an antibody specialist in its latest oncology M&A deal with plans to add the platform tech

Whatever Servier learned about Symphogen during their 2-year development alliance must have significantly whetted their appetite for an acquisition.

Paris-based Servier announced Friday that it has struck a deal to buy out the antibody expert. The acquisition comes 2 years after Servier acquired Shire’s cancer business for $2.4 billion. They’ve been working with Symphogen on a slate of programs, including some favs – PD-1, LAG3 and TIM3 — where they are looking to differentiate themselves from the more prominent drugs in these niches.

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April 3, 2020 09:55 AM EDT

Endpoints Staff

Peer Review

GSK vaccine chief heads for AIDS vaccine initiative; Pfizer enlists Sue Desmond-Hellmann to its board of directors

→ Rip Ballou, who until very recently led vaccine research and development at GlaxoSmithKline, is joining the International AIDS Vaccine Initiative (IAVI) to lead its USAID-funded ADVANCE program. The program uses a network of researchers and institutions in Africa to help develop a vaccine for HIV. Ballou had worked at GSK since 2010 and has led global vaccine R&D since 2015. Prior to that he held posts at the Bill & Melinda Gates Foundation, a different post at GSK, Medimmune, and Walter Reed Army Institute of Research. IAVI is led by Mark Feinberg, the former CSO of Merck Vaccines.

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April 2, 2020 06:23 PM EDTUpdated 1 hour ago

Endpoints Contributor

Biotech Voices

Coronavirus

Drug discovery in the age of coronavirus

Developing new drugs is incredibly hard. That’s why, despite superhuman efforts from the industry, we’re still looking at 12-18 months minimum before we can realistically hope for a vaccine for Covid-19, and probably months before there’s a proven viable drug treatment.

But our increasing ability to begin to industrialize the drug discovery and development process through an engineering approach means that we have more hope for speeding up this process than ever before — and not just to defeat coronavirus, but to benefit the development of all new medicines in the future.

April 1, 2020 07:26 AM EDTUpdated 09:47 AM

John Carroll

Coronavirus

Regulatory

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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