Merck’s announcement last week that an experimental HIV combo therapy resulted in a drop in immune cell counts, and its subsequent decision to halt a Phase II study, is starting to see a snowball effect.
Late Tuesday afternoon, the pharma giant and partner Gilead said they are pausing enrollment of a separate study using one of the investigational compounds from Merck’s solo trial. The move was made ‘out of an abundance of caution’ after Merck stopped the other study, the companies said, allowing investigators to consider potential modifications.
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Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs
Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.
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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.
The FDA has slapped a clinical hold on the early-stage program for one of Kura’s cancer drugs following a patient’s death in a clinical trial.
The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.
Kura’s stock swiftly plunged 30% on the news.
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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)
As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.
GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.
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Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.
Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.
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Just a month after it seemed like negotiations were getting nowhere fast on waiving the intellectual property around Covid-19 vaccines ahead of a December deadline, the European Commission has now gone from threatening to veto any IP waiver to calling for a waiver.
The push for an IP waiver at the WTO is part of efforts to get more shots in the arms of people in low- and middle-income countries. Less than 1% of doses worldwide have been administered in low-income countries so far.
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John Oyler (Photographer: Paul Yeung/Bloomberg via Getty Images)
Months after announcing plans to build a new manufacturing campus in Hopewell, NJ, BeiGene has closed on the 42-acre site at the Princeton West Innovation Park Tuesday.
The company, which is focused on developing and commercializing cancer medicines, announced that it will house manufacturing and clinical R&D at the site, in an effort to boost its supply chain.
The first stages of the project will cost ‘several hundred million dollars,’ and the facility will include 400,000 square feet of commercial stage biologic manufacturing, along with 16,000 liters of capacity and clinical R&D and office space. The construction will start in 2022, and wrap up in late-2023 or 2024. Another 1 million square feet worth of space leaves the door open for future expansion.
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Joan Perelló, Sanifit CEO
Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.
Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.
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Christophe Weber, Takeda CEO (Miho Takahashi/The Yomiuri Shimbun via AP Images)
After a wild two-decade ride, the FDA has approved Takeda’s antiviral maribavir — now marketed as Livtencity — for cytomegalovirus, one of the most common viral infections experienced by transplant patients.
Takeda picked up maribavir a couple years ago in its $62 million Shire buyout, at which point the drug had already failed a Phase III trial and changed hands a few times. But on Tuesday, Takeda touted a regulatory win in patients 12 years and older, marking the second approval this year for one of the company’s new molecular entities.
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John Oyler, BeiGene CEO (Endpoints News, PharmCube)
BeiGene was among the first China-based biotech companies to list on Nasdaq and made history by raising $903 million in its secondary listing in Hong Kong. Now, it’s ready to pull a hat trick as it launches its proposed IPO on Shanghai’s STAR Market.
The biotech is reportedly looking to raise as much as $3 billion from selling about 8.62% of its total outstanding shares.
With roots in Beijing, BeiGene has planted its foot all the way across the Pacific under founding CEO John Oyler, who has offered a grand vision to deliver world-class oncology drugs by leveraging discovery talents and clinical trial infrastructure in China while looking to the world — a vision that sees ‘no borders.’
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https://endpts.com/mercks-pause-on-an-hiv-program-snowballs-as-a-gilead-partnered-trial-is-shoved-into-limbo/
