NurOwn, Brainstorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.

Digital therapeutics developer Click Therapeutics is partnering with Indivior to develop a mobile app for substance use disorder. Indivior is now Click’s third development partner, following deals with Boehringer Ingelheim and Otsuka Pharmaceutical.

GSK claims that Pfizer’s FDA-approved vaccine for respiratory syncytial virus infringes on four patents protecting its own approved vaccine, Arexvy. The patent suit comes with the RSV season approaching.

TG Therapeutics’ multiple sclerosis drug Briumvi will be commercialized in Europe by Neuraxpharm. The Germany-based company paid $140 million up front for certain rights to the drug, which received European Commission approval in June.

Pfizer’s Litfulo is the first treatment approved for treating adolescents with severe alopecia areata. The drug’s approval also covers adults, were it will compete against Eli Lilly’s Olumiant.

Marstacimab, a Pfizer drug for both hemophilia A and B, met the main goal of a Phase 3 study and the company now plans to discuss the data with regulators. The Pfizer drug could beat to the market a Novo Nordisk drug that addresses the same novel target.

Enzo BioChem’s sale of its clinical lab business to Labcorp is the culmination of a monthslong strategic review. Meanwhile, diagnostics and lab testing giant Labcorp is in the middle of its own corporate shakeup as it readies its clinical trials business for a spinoff as a standalone, publicly traded company.

Royalty Pharma’s milestone payment from the approval of Pfizer migraine drug Zavzpret stems from financing deals struck with the therapy’s previous developer, Biohaven Pharmaceuticals. Royalty Pharma is also in line to receive royalty payments going beyond the next decade.

Pfizer is no stranger to antibody drug conjugate cancer therapies, but it hasn’t been commercially successful with them. The pharma giant’s agreement to acquire Seagen for $43 billion will thrust it to the forefront of the ADC drug class, which has become a hot space for research and regulatory activity in recent years.

Orserdu, a drug from Menarini Group subsidiary Stemline Therapeutics, is now approved for treating breast cancers that carry the ESR1 mutation. The drug is the first approved oral therapy from a class of therapies called selective estrogen receptor degraders (SERDs).

BrainStorm Cell Therapeutics’ stem cell therapy for amyotrophic lateral sclerosis received an FDA refuse-to-file letter, correspondence that informs a company its application seeking approval is incomplete. The notice means BrainStorm might need to run another clinical trial.

Sanofi will use Insilico Medicine’s tech to advance drug development candidates for up to six new targets. Disease indications were not disclosed, but the pharmaceutical giant said the new agreement will boost its drug discovery research in China.

Pfizer’s respiratory syncytial virus vaccine candidate infants has clinical data showing it helped prevent severe infections in infants. It’s a maternal vaccine that produces antibodies in the mother that confer temporary protection to a baby.

Alban de La Sablière, global head of partnering at Sanofi for the past six years, has joined artificial intelligence biotech Owkin as its first chief business officer. In addition to finding more business partnerships, de La Sablière will also oversee expansion of Owkin’s internal drug and diagnostics pipeline.

A professor of healthcare policy at Harvard Medical School shared research with the committee concluding that COVID-19 outbreaks in nursing homes were largely a function of where in the country a nursing home was located versus other specifics about the facility. 

Pfizer and BioNTech have completed their filing seeking FDA emergency use authorization of their omicron-adapted Covid-19 booster shot. Production of this bivalent vaccine has already begun, enabling the companies to begin distribution as soon as the FDA authorizes the shot.

The FDA has approved Axsome Therapeutics drug Auvelity as a treatment for major depressive disorder in adults. The regulatory decision makes the twice-daily pill the first new oral drug approved to address a novel depression target in more than 60 years.

Pfizer’s own R&D efforts in sickle cell disease have fallen short, so the pharmaceutical giant is turning to M&A to gain a presence in the blood disorder. The acquisition of Global Blood therapeutics brings the commercialized drug Oxbryta plus a pipeline of other therapeutic candidates.

Regeneron Pharmaceuticals has big plans for cancer immunotherapy Libtayo and it believes it can better execute on them if it has full control of the drug, currently partnered with Sanofi. Regeneron struck a deal to pay Sanofi $900 million, plus another $200 million in milestones, to secure full global rights to the asset.

When consumer healthcare products joint venture Haleon spins out from GSK as an independent company next month, Pfizer will sell its minority stake in the business. Pfizer said that selling its ownership in Haleon is keeping with its focus on developing innovative new medicines and vaccines.

Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.

Regeneron Pharmaceuticals is paying $250 million cash to acquire Checkmate Pharmaceuticals, a clinical-stage biotech developing drugs that activate the innate immune system. The biotech’s lead drug candidate is currently in pivotal testing in melanoma.

Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.

Sanofi and digital therapeutics company DarioHealth will work together to promote the tech firm’s offerings for the management of chronic diseases. Under the $30 million, multi-year agreement, the partners will also develop new technology tools.

After reviewing Phase 2B clinical data, the New York drugmaker and its partner Ionis Pharmaceuticals announced that Pfizer was abandoning the development of a cardiovascular drug, thereby returning the rights to Ionis.

Topography Health announced their 27.5M series A funding for their clinical trials technology led by Andreessen Horowitz and Bain Capital Ventures.

Andrew Bott, Director of Talent Acquisition in EMEA & APAC countries at Medidata, shared his insights on hiring trends in this sector, in response to emailed questions.

The FDA has rejected Pfizer’s somatrogon, a long-acting form of human growth hormone designed for once-weekly dosing. The setback delays Pfizer and partner Opko Health from competing against a newly approved human growth hormone drug from Ascendis Pharma that is also designed for once-weekly dosing.

Eleusis is developing a formulation of the psychedelic compound psilocybin that overcomes limitations of pill versions of the drug. Depression is Eleusis’s lead disease target but the biotech notes that its research has shown the potential to bring psychedelic drugs beyond psychiatry.