Research & Development
Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression
The draft would allow drugmakers to share off-label economic data with payers, a practice that until now has been considered taboo, and require the FDA to assess patient experience data in regulatory decisions, in addition to boosting funding for the NIH.
IBM takes on healthcare data; Mylan settled a lawsuit allowing it to launch generic Viagra by 2017; an FDA committee will meet today to discuss Onglyza
Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times
The Paris-based drugmaker's global president of R&D said that jumping through different and inconsistent regulatory hoops puts an "enormous" cost on drugmakers.
The SEC said some company drug prices can be made public, 23andMe launched an R&D division, and Public Citizen is asking the FDA to withdraw a proposal it says will undermine drug safety information.
The Paris-based drugmaker has axed 100 oncology and global R&D employees as part of a reorganization effort.
Researchers say the golden-age of profits appears to be over, and the industry may need help funding innovation.
BMS halts cancer drug trial over positive Phase-III results; Shire has acquired NPS Pharmaceuticals for $5.2 billion; 23andMe expands Pfizer agreement.
Shire may bid on NPS Pharmaceuticals; Amgen says cancer drug will cost $178,000; Takeda has a new head of R&D.
Bayer consolidates OTC creative portfolio; Genentech R&D head steps down; Novartis receives approval for orphan drug.
Researchers say the average cost of bringing a drug from concept to approval, and through post-approval assessments for reasons such as new doses or formulations, hovers at around $2.8 billion per drug in 2013 dollars.
A 4-1BB agonist highlights a discussion with analysts on the drug giant's immunoncology pipeline, with a number of combination options to be tested next year.
For example: Tufts Center for the Study of Drug Development reseachers say it takes 18% longer to develop CNS drugs than it does non-CNS drugs.
Thomson Reuters finds the pharmaceutical industry is getting better at abandoning failures earlier.
FDA feedback will influence a new clinical trial design, but the regulator's recent reaction was a bit of a surprise.
CureDuchenne is giving biotech Prosena $7 million to help its Duchenne Muscular Dystrophy treatment move along.
Researchers find worries about being misunderstood or mixed in with "junk" news are among the reasons academic researchers are keeping their data points out of the social media swirl. Researchers say this fear is at the expense of a faster way to make an impact on public policy.
The drugmaker says the therapeutic approach has a narrow treatment potential.
The drugmaker was scant on details, but Phase-III ramucirumab results among non-small cell lung cancer patients showed increased overall and progression-free survival vs. placebo.
Ten pharma companies will share money and biomarker research under an NIH collaboration.
168 employees will be pink-slipped this quarter.
The company known for Eylea has launched a genetics discovery unit and teamed up with a partner to sequence 100,000 patient genomes.
Mid-stage data show the drug, romosozumab, was associated with significant increases in bone mineral density compared to Lilly's Forteo and off-patent Fosamax.
The move is designed to help the drugmaker pursue more external transactions to bulk up its product line.
A recent poll shows a strong desire among web-savvy patients to play a more active role in medical research.
The company's pursuit of a tighter research focus follows a path very much like that of its peers.
AstraZeneca and Roche strike antibiotic deals.
Monday's announcement builds on a stream of recent R&D relationships.
The midnight shutdown put 800,000 government employees on leave, including those at the FDA, NIH and CDC.
A wave of more effective anti-cancer drugs has set the oncology world on fire with enthusiasm. While many hail this as a new era, an equally vocal faction questions the money spent for the value gained. This medical and commercial trend report for marketers of anti-cancer modalities touches on many of the latest shifts that have expedited product launches and otherwise impacted promotion and reimbursement of these drugs. Click here.
Pharma continues to struggle with its image. Exhibit A is the public debate around the price of, and access to, new and innovative meds. As countless transformative technologies hit market, has industry done enough to anchor its permission to innovate? To provide a closer look at trends affecting trust over the past year, MM&M presents this e-book, "The 2015 Edelman Trust Barometer." Click here.