Bio Pharma Dive

Lilly wins FDA approval of new kind of diabetes drug

Bio Pharma Dive

Tirzepatide, now branded as Mounjaro, helped improve blood sugar control in testing and has been shown to have powerful weight loss effects as well, making it one of the most closely watched drugs in Lilly's pipeline

In first, Verve gets clearance to test base editing inside the body

Bio Pharma Dive

Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K.,

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Pfizer to acquire Biohaven in $11.6B bet on biotech's migraine drugs

Bio Pharma Dive

The rest of Biohaven's pipeline, which includes drugs for ALS and obsessive compulsive disorder, will be spun out into a new company led by the biotech's current CEO and retaining its name

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Making sub-visible particles visible

Bio Pharma Dive

Sub-visible particles can lower the effectiveness of a drug, which is why regulatory authorities are demanding processes be developed, validated and set up in such a way as to minimize all forms of contamination

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

Why choosing the right primary container is crucial

Bio Pharma Dive

New mRNA technology: identifying the right drug containment solution is more important than ever

Moderna's finance head is out as former employer conducts investigation

Bio Pharma Dive

Jorge Gomez, who officially took the CFO reins Monday, lasted one day on the job. His departure comes as Gomez's previous company, Dentsply Sirona, looks into financial allegations against current and former executives

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Clay Siegall, founding Seagen CEO, takes leave amid domestic violence accusation

Bio Pharma Dive

The company's board is investigating the allegation, which Siegall, who has led Seattle's largest biotech for 24 years, denied. Chief Medical Officer and former Merck executive Roger Dansey was named interim CEO

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Biogen CEO to step down as company pulls back from Alzheimer's drug

Bio Pharma Dive

Michel Vounatsos, Biogen's CEO since 2017, will be replaced as the company "substantially" eliminates the commercial workforce around Aduhelm, which has generated paltry sales in the face of resistance from insurers and doctors

Novartis suspends production of two radiopharmaceutical drugs over quality concerns

Bio Pharma Dive

Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily

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Key Bristol Myers drug holds up in long-term psoriasis study

Bio Pharma Dive

Deucravacitnib, forecast by Bristol Myers to hit $4 billion in peak sales, is under FDA review with an approval decision due by September. The agency's view of its safety will be key to its future

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FDA approves oral version of Mitsubishi's ALS drug

Bio Pharma Dive

Called Radicava ORS, this version is taken by mouth rather than via an hourlong infusion, which may help improve the drug's convenience and use

J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

Bio Pharma Dive

The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies

FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect

Bio Pharma Dive

The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake

Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

FDA rejects two China-developed cancer drugs

Bio Pharma Dive

The regulator cited concerns around single-country trials in turning back Hutchmed's pancreatic cancer treatment, while manufacturing issues held up Junshi and Coherus' throat cancer medicine

Against a historic market downturn, Moma Therapeutics raises $150M for precision cancer research

Bio Pharma Dive

The biotech's Series B round, which kicked off early this year, should be able to fuel its work on "molecular machines" until at least 2024, according to CEO Asit Parikh

PatientLink by TrialCard: The digital patient support platform

Bio Pharma Dive

New offering aligns with industry shift towards healthcare consumerism and empowers life science leaders to deliver highly personalized patient support experiences

AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

Bio Pharma Dive

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway

FDA clears Pfizer to restart Duchenne gene therapy trial, with new safeguards

Bio Pharma Dive

The regulator has asked Pfizer to closely monitor patients in a hospital setting for a week as part of a deal to end a study suspension that's lasted more than four months

Spero to lay off 75% of workforce, change strategy after FDA challenges study results

Bio Pharma Dive

Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring

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Vertex surprised by FDA halt of diabetes cell therapy study

Bio Pharma Dive

The regulator determined Vertex had "insufficient information" to test higher doses of the therapy, which showed promise in the first two patients treated

Ionis, AstraZeneca change a key trial, fueling more questions about a genetic heart disease

Bio Pharma Dive

The partners increased the size and length of a large, ongoing study in transthyretin amyloidosis cardiomyopathy, a decision that has implications Alnylam Pharmaceuticals, which is testing two of its drugs against the disease

Biogen, having scrapped Aduhelm, tries to convince investors of turnaround plan

Bio Pharma Dive

Though executives claimed that inking deals and derisking research programs are priorities, analysts questioned whether any meaningful strategic changes will occur in the near term

Satellite Bio launches with new approach to bioengineering tissues

Bio Pharma Dive

Backed by $110 million in venture funding, Satellite is led by Dave Lennon, formerly head of Novartis Gene Therapies

Solid Bio joins slate of biotech layoffs, shedding 35% of its workforce

Bio Pharma Dive

The company is the latest in a growing list of gene therapy developers to restructure and cut jobs during an industry-wide downturn

A promising cancer drug leads Regeneron to reconsider its aversion to M&A

Bio Pharma Dive

Regeneron has agreed to purchase Checkmate Pharmaceuticals for $250 million, the first acquisition of a publicly traded company in the biotech's nearly 35-year history

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GSK to test FDA's tough stance on anemia pills

Bio Pharma Dive

Unlike treatments from Akebia and FibroGen, GSK's drug hasn't been tied to a higher risk of heart problems, potentially easing the agency's concerns

Drugs 258

Regeneron, in search of an eye gene therapy, turns to a young biotech

Bio Pharma Dive

Facing mounting competition to its top-selling drug Eylea, Regeneron is teaming up with ViGeneron to develop a genetic medicine for an inherited retinal disease

Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds

Bio Pharma Dive

A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year

Moderna vaccine sales surpass expectations as company looks to fall boosters

Bio Pharma Dive

The trajectory of COVID-19 vaccine sales is now harder to predict amid questions about the rollout of additional doses and whether purchasing in the U.S. might shift from the federal government to private payers

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Imara to reduce staff by 83% amid biotech shakeout

Bio Pharma Dive

The planned job cuts were announced days after Imara — one of three spinouts from the drug accelerator Cydan Development, stopped development of its top medicine

Seagen CEO Siegall resigns amid domestic violence investigation

Bio Pharma Dive

The biotech company is searching for a permanent successor to Siegall, who was arrested last month for alleged domestic violence. CMO Roger Dansey will continue as interim CEO

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Medicare finalizes policy limiting coverage of Biogen Alzheimer's drug

Bio Pharma Dive

Treatment with Aduhelm would only be covered for patients enrolled in a clinical trial under the policy, which largely follows a draft proposal released in January

As biotech retreats, gene therapy companies retrench and redraw plans

Bio Pharma Dive

At least nine biotechs working in cell or gene therapy have announced layoffs, cost cuts or restructured their research since December — restructurings that have coincided with a stock market downturn

Gilead gets cell therapy boost with FDA clearance of Maryland factory

Bio Pharma Dive

The new site in Frederick, Maryland will be used to produce Yescarta, which this month won an expanded approval that substantially widens its market

AstraZeneca and Daiichi set to broaden use of breast cancer drug, challenging Roche

Bio Pharma Dive

The FDA cleared Enhertu for second-line use in HER2-positive disease, the latest inroads the partners have made against Roche’s dominant portfolio of breast cancer medicines

Traditional and bespoke registries

Bio Pharma Dive

In order to truly understand the lived experience of a patient with a given condition or disease, several types of real-world data sources should be analyzed

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GSK acquires Sierra Oncology, betting $2B on a bone cancer drug with a long history

Bio Pharma Dive

The British pharma is buying into the potential of a medicine meant to treat the anemia often associated with myelofibrosis, a complication that isn't adequately addressed by current therapies