Ursula von der Leyen (Christian Hartmann/Pool Photo via AP Images)
Pfizer is suing its former associate director of clinical statistics in a California court after she uploaded thousands of files to her personal Google drive in October and then misled the company about what she took and where the files are today.
According to the complaint filed Tuesday evening, Chun Xiao (Sherry) Li uploaded over 12,000 files — including scores of confidential Pfizer documents — from her Pfizer-issued laptop to a personal account and when Pfizer addressed the issue with her, she initially gave the appearance of cooperation, but instead misled Pfizer about what she took, how she took it, when and why she did it.
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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.
Learn more about Avance ClinicReady here.
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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 Oncology’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.
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Amidst a push to ease pressure on the supply chain domestically, BD Biosciences will expand at the San Diego Reagent Innovation Center, as the property developer announced the company’s plans Monday.
The San Diego site will be at Torrey View, a 10-acre life sciences R&D campus that Breakthrough Properties is creating alongside Mitsui Fudosan America. It’s within the life sciences cluster of Del Mar Heights, which offers nearby housing for employees in biopharma.
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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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Robert Califf (Pablo Martinez Monsivais, AP Images)
President Biden’s nominee to run the FDA was hit with some tepid criticism back in 2016 for being too cozy with the biopharma industry because some of the trials he ran had industry sponsors and some of the funding he took was from industry.
Nevertheless, Rob Califf sailed through his confirmation then, and his successor Scott Gottlieb showed that even closer ties to industry shouldn’t stop an effective leader from being FDA commissioner.
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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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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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A nonprofit dedicated to transparency is calling on the FDA to release any and all documentation related to the approval of the Pfizer/BioNTech Covid-19 vaccine. And while FOIA requests are notorious for taking months if not years to fulfill, this time the FDA is asking for 55 years to complete the request.
After the FDA denied expediting the group’s FOIA request, the nonprofit sued FDA in the US District Court in northern Texas, attempting to compel the agency to expedite their request, which was that FDA turn over about 329,000 pages of documents in less than 3 months.
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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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https://endpts.com/covid-19-roundup-european-officials-recommend-vaccine-boosters-ahead-of-winter-surge-canada-becomes-first-country-to-approve-jjs-vaccine/
