Latest Biotechnology, Pharmaceutical and Healthcare News from BioPharmaDive

06:30 EDT 26th September 2018 | BioPortfolio

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Showing News Articles 1–25 of 1,200+ from BioPharmaDive

Tuesday 25th September 2018

Takeda's dream of a first-line ALK inhibitor supported by late-stage data

Pfizer, Roche and Novartis all have first-line drugs for ALK-positive lung cancer, putting pressure on Takeda to keep up in the increasingly competitive market.

Novartis to cut 2,500+ jobs in the UK and Switzerland

One English and four Swiss manufacturing plants, as well as about 700 positions mainly located at the company's Basel campus, will be affected.

AstraZeneca's Imfinzi shows its strength in Stage 3 lung cancer

Results released at World Lung spell out the cancer immunotherapy's survival benefit, bolstering AstraZeneca's place in the earlier, locally advanced setting.

Monday 24th September 2018

Tecentriq sets the bar in small-cell lung cancer

Roche owns the first successful Phase 3 study of an immunotherapy in the less-common lung cancer type. But others are closing in.

AstraZeneca heart study delivers mixed results for diabetes drug

The pharma hopes the results will help Farxiga compete with Eli Lilly and Boehringer Ingelheim's rival Jardiance, which has carved out a leading position on the strength of its heart claims.

Gilead creates subsidiary to sell generic versions of hep C blockbusters

Asegua Therapeutics will sell authorized generics of Harvoni and Epclusa at an annual list price of $24,000 for the most common course of therapy.

J&J still has much to explore with continuous manufacturing

More than two years after getting an OK to switch Prezista manufacturing from batch to continuous, the big pharma has no intention of backing away from the increasingly turned-to method of production.

As FDA and pharma warm to continuous manufacturing, generics stay skeptical

Generics companies worry continuous manufacturing could become another tool for branded drugmakers to protect their products.

For CDMOs, continuous manufacturing isn't an 'if,' but a 'how'

Contract services providers are receiving more interest from drugmakers keen on the technology's potential cost-savings and better efficiency.

Pharma's slow embrace of continuous manufacturing

On the whole, drugmakers remain wedded to traditional production styles that have served for decades. Some, however, are shifting to newer technology.

FDA's Woodcock on drug companies' sluggish march toward manufacturing's future

The CDER chief said the agency won't force companies that want to stay "in the 1940s" with traditional methods — as long as they meet FDA standards.

Sarepta clears up clinical hold for gene therapy

The micro-dystrophin program for Duchenne muscular dystrophy looks back on track roughly two months after regulators put it on pause.

Foundation Med advances liquid biopsy ambition with new test

Launch of FoundationOne Liquid will expand the Roche-owned firm's liquid biopsy offerings as demand for blood-based cancer testing grows.

Vascepa's big heart benefit pumps up Amarin's value by $2B

Amarin's CEO called it "the single most significant advance in preventative cardiovascular drug therapy since the advent of statin therapy."

What cheap data means for understanding the patient experience in clinical trials

More nuanced, dynamic insights into patient experience can decrease the burden on patients by extrapolating from objective data sources and reducing the number of questionnaires being asked.

UK High Court OKs Avastin off-label use in wet AMD

Doctors in the north of England have won the right to use Avastin to treat wet age-related macular degeneration.

Amgen faces a bigger European challenge to Neulasta

Three biosimilar competitors to the blockbuster drug received backing from a key European committee last week.

Friday 21st September 2018

Amazon-JPM-Berkshire venture reportedly hires consulting powerhouse

The move comes weeks after the Atul Gawande-led venture tapped Jack Stoddard to be its chief operations officer. 

Sarepta strikes out again with European regulators

Despite backing more than a dozen other drugs at its September meeting, the CHMP for a second time refused to support eteplirsen's marketing OK.

Narcan developer secures grant for counter to opioid weaponization

BARDA is concerned that repeat doses of naloxone would not be available in a large-scale terrorist attack involving weaponized opioids. So it's tapped Opiant to develop a long-acting opioid overdose agent. 

Acadia shares rise after FDA review of Nuplazid

Following reports of increased risks to Acadia's Parkinson's drug, an analysis by the regulator turned up no new safety findings.

How do doctors feel about robots in the exam room?

ZS’s 2018 research finds that only 25% of doctors are comfortable letting AI help with diagnosis.

Thursday 20th September 2018

Prescriptions, outpatient care drive healthcare spending growth: report

The Health Care Cost Institute found employer-sponsored insurance spending increased by 44% over the decade through 2016. 

Pharma manufacturing snaps back to life after Florence

Damage from flooding brought by the storm was severe, but drugmaker production facilities appear to have avoided major disruptions to operations.

Phase 3 win underscores that Astellas is more than Xtandi

Though better known for the prostate cancer med, Astellas gets considerable revenue from bladder drugs and reported positive data Thursday for an experimental chronic kidney disease therapy.

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