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- Another Pfizer gene therapy is free of FDA hold, but delay continues
- Sierra wanted a partnership, but GSK wanted the store: How the $1.9B buy out came to be
- Bad news from FDA prompts Spero to lay off 75% of staff, drop UTI drug
- Sponsored: Progress with Promise with Ibex® Design’s 11-month DNA to IND guarantee
- Early clinical data on psilocybin in anorexia point Compass to potential new opportunity
- Sponsored: With the makings of a hub, NYC primed to be life sciences leader
- After a dismal last year, Sesen Bio grasps for alternatives to stay afloat
- Tackling toxicity, Tubulis lands $63M to advance ADC pipeline spearheaded by Adcetris rival
- As expected, FDA spikes down Axsome migraine med, but issues are 'addressable'
- Biogen takes another dip into Scribe gene therapy collab with another disease target
- Patient Square Capital invests $300M to support 'golden age of therapeutics' with Enavate Sciences
- Dianthus to follow 'north star' on mission to reduce autoimmune injections with $100M funding
- Biogen CEO steps down amid Aduhelm fallout as biotech trims commercial team in $1B overhaul
- Wearable, AI-powered whole-breast ultrasound system cleared by the FDA
- OIG report reignites lawmakers' push for action on Medicare Advantage prior authorization
- 'The Top Line' podcast: Pharma advertising shifts gears and Novartis taps a surprising M&A czar, plus this week's headlines
Featured Story | By Gabrielle Masson Another of Pfizer's gene therapies had been freed from an FDA clinical hold, but the study is not set to get underway immediately. read more |
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Top Stories By Annalee Armstrong Sierra Oncology was ready to take momelotinib to the market, but they needed help. What started as an effort to find a strategic partner turned into a $1.9 billion buyout from GlaxoSmithKline, which didn’t just want an arms’ length deal. Chief Commercial Officer Luke Miels wanted it all. read more By James Waldron With the future of its urinary tract infection drug in doubt, Spero Therapeutics has resorted to laying off three-quarters of its staff and dropping and pivoting to its mid-stage pipeline. read more Sponsored By: Lonza AG Exactly what you need from your DNA to IND partner to succeed. A unique guarantee of speed and quantity, backed by Lonza’s 35 years of experience in biologics, for a fixed price. read more By Nick Paul Taylor Compass Pathways has early evidence that its psilocybin therapy can improve outcomes in people with anorexia nervosa. Working with anorexia expert Walter Kaye, the British biotech showed 40% of subjects in the small study experienced clinically significant reductions in eating disorder psychopathology after a single dose of the active ingredient in magic mushrooms. read more Sponsored by: New York City Economic Development Corporation With a $1 billion public investment, diverse talent and science, space, and funding, NYC emerges as a global leader in life sciences. read more By Max Bayer Sesen Bio is weighing up its options, including a potential sale or merger, after a dismal last year has left its potential cancer drug hanging by a thread. The company also said it plans to meet with regulators again in the coming weeks to finalize details pertaining to an additional phase 3 trial. read more By Nick Paul Taylor Antibody-drug conjugates have come a long way in recent years. Tubulis wants to advance the modality still further—and has pulled in $63 million to bankroll technology to address the persistent toxicity problems facing the field. read more By Max Bayer The FDA formally rejected Axsome's migraine med, but the company believes the unresolved issues are "addressable." The complete response letter was expected after the company disclosed the regulator's outstanding flags last week. read more By Max Bayer Biogen is double-dipping into a 2020 collaboration with Scribe Therapeutics, exercising its option for an additional neurological disease target in gene therapy using the biotech's CRISPR technology. read more By Gabrielle Masson Healthcare investment firm Patient Square Capital sees a bright future in therapeutics—despite a bear market—cashing in $300 million to form portfolio company Enavate Sciences, which will work to support and grow a series of therapeutics companies. read more By James Waldron,Gabrielle Masson Needlephobics rejoice! Dianthus Therapeutics is on a mission to reduce the number of injections autoimmune disease patients have to receive, and will use $100 million in series A financing to send its lead antibody candidate into the clinic this year. read more By Angus Liu Biogen’s yearlong struggle with the controversial FDA approval and launch of Aduhelm has culminated in a deep overhaul reaching all the way to the CEO. read more By Andrea Park Scanning the entire breast volume with iSono's Atusa system takes only about one minute per side—a far cry from the 10 to 15 minutes it can take to complete manual probing. read more By Robert King A major new report from an HHS watchdog on prior authorization denials in Medicare Advantage sparked an urgent effort to get Congress to act on the issue. read more By Teresa Carey This week The Top Line podcast discusses pharma's ad spending for 2021, an intriguing executive move at Novartis and more. read more Resources Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored By: H1 More than 570 clinical trials in Ukraine have been disrupted. Unanticipated disruptions to medical testing and clinical trials impede progress toward new breakthroughs and new therapies that millions of patients around the world hang their hope on. What role do rescue sites play? Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. 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