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- Analysts: New FDA rules inspire tougher drug reviews
- India's Cipla outlines big biosimilars plans, new R&D deals
- Which biotechs are the least efficient?
- Big Pharma takes on risk with biosimilar programs
- Vaccine sales up 16% in 2009
- Data-sharing breeds Alzheimer's progress
- Endo buying partner in pain Penwest for $168M
- Senators advocate blockbuster remedy for rare drug woes
- NEJM spotlights Provenge study
- Sandoz chief predicts big wave of biosimilars
- BREAKING NEWS: Report: Sanofi approaches Genzyme with buyout deal
- Only the biggest developers can play the biosimilar game
- Fitch projects 23 new drug filings for 2010
- GSK chief backs a centralized European approval process
- Analysts score the FDA expert panels' approval ratings
- Cipla targets $19B biosimilar market with string of new deals
- Pfizer creates a new R&D unit for rare diseases
- Hospira gains EMA OK for Neupogen biosimilar
- FDA proposes controversial release of complete response letters
- Regenerative medicine could be $20B market in 15 years
- Report: U.S. cancer trials are in a state of crisis
- Researchers take a fresh look at hallucinogens
- Biotech wins 12-year haven with passage of reform bill
- FDA, NIH partnership promises better science, faster reviews
- Is Obama backing down on biosimilars?
- BIO chief maps salvage plan for the 12-year umbrella
- FDA wants more studies of Vibativ for pneumonia
- BREAKING NEWS: Pfizer dumps about 100 drug development programs
- The FDA new drug approvals of 2009
- Blockbuster data: Studies back efficacy of late-stage MS pills
- Republican win in Mass. could derail a biotech victory
- Obama mounts fight against 12 years of data exclusivity
- Would complete disclosure cure the NDA-rejection rash?
- Biotech faces the tipping point for personalized meds
- Roche touts Actemra results for sJIA
- Top 10 Blockbuster Biotech Drugs
- Lobbyists figure heavily in biogenerics debate
- New bill boosts federal funding for biotech
- Harvard experts champion 5-year window on generic protection
- FDA rejects new indication for Spectrum drug
- AIDS vax offers new hope
- Is the biotech venture glass half empty or half full?
- Bestselling Drugs of 2008
- Is the bar set too low for new cancer drugs?
- Is placebo effect to blame for weak R&D record?
- FDA opens up access to experimental meds
- Sanofi charges into human trials with H1N1 vax
- Is denosumab a must-win for Amgen?
- Survey says: Canadian biotechs in big trouble
- Pfizer plans dramatic increase in new cancer drugs
- Examining the generic biologics debate
- Tempers rise as biosimilar debate reaches a boil
- FDA asks for more Zevalin info
- Roche recasts itself as a Big Biotech
- FDA reform advocates want trial, data transparency
- PARP inhibitor posts impressive tumor results
- Biologics will dominate in 2014
- BREAKING NEWS: Novartis takes lead position in race for swine flu vax
- FTC: 12-14 years too much protection for biologics
- New drug class takes center stage at ADA conference
- Waxman urges Obama to bust open biogeneric pathway
- Doctor demands halt to FDA review of Lilly's prasugrel
- FDA begins move to unveil secret data
- Biosimilars, reform efforts spur BIO lobbying
- Blockbusters face a final decision from FDA
- Amgen's Sharer plots biosimilar counterattack
- Shrinking drug patents can scuttle new blockbusters
- Researchers launch new programs for swine flu vax
- Scientists crack swine flu genetic code
- FDA OKs emergency drug use to combat flu outbreak
- AZ wins expert panel support for lung cancer drug
- Feds double money for cancer research
- NIC researchers develop new Phase 0 cancer trial
- Nuvigil a success in jet lag study
- Google's $100M venture arm looking for biotech partners
- Roche seals Genentech takeover
- Appeals court supports patent rule opposed by developers
- Merck Serono to invest $55M in start-up biotechs
- Biosimilar bill offers 12 years of market exclusivity
- Obama taps Hamburg as new FDA chief
- TNF-antibodies top biologic sales for 2008
- Roche seals deal for Genentech at $95 a share
- Hamburg chosen as FDA chief, Sharfstein as deputy
- Lawmakers propose biogeneric bill
- Drug R&D spending surges in sinking economy
- Report: Genentech and Roche near $46.7B deal
- Merck to buy Schering-Plough for $41.1B
- Companies turn to web 2.0 to recruit for trials
- Genentech shows off its pipeline prospects
- Obama to back biogenerics
- NicOx hunting for acquisitions as NDA looms
- Burrill: Biotech achieves profitability as crisis bites
- Genzyme lines up $600M for personalized meds
- MA-based Dynogen files for bankrupcy
- Elan cuts 230 jobs as it waits for trial results
- FDA erred in excluding expert from review
- Pfizer shelves two (unpromising) drug programs
- Analysts plot strategy as Genentech rejects Roche
- Roche raises $16B for Genentech bid
- Raising alarms, study sees trials migrating abroad
- India's biotech industry grows at 20% clip
- Novogen cuts staff, focuses on oncology
- Merck acquires biosimilars in $130M pact
- Investors: biotech to rebound, outperform in '09
- KV cuts 700 jobs following manufacturing problems
- Biogen's Tysabri sales disappoint Street
- Roche confident of Genentech success
- Merck willing to consider major buyout
- Sanofi lining up billions for a major buyout
- Will BMS be the next big takeover target?
- FDA keeps heat on data--but lets itself off the PDUFA hook
- FDA approvals up in '08, missed deadlines abound
- Study: Keep patients informed about trial outcomes
- Diabetes drugs face higher hurdle at FDA
- Bird flu outbreaks raise fresh fears of an epidemic
- Pain shares tumble as FDA asks for Remoxy data
- Vivus touts late-stage success with obesity drug
- More biotechs lobby against biogenerics
- Biotech leaders to ask Congress for bailout
- Amgen, Amylin lobby against biogenerics
- FDA panel backs Novartis malaria drug
- Roche hit with major delay on Actemra approval
- Mannkind boasts of success in Phase III inhaled-insulin studies
- FDA reviewer confirms drug's alluring side effect
- Big studies don't always change doctors' habits
- 2008 NME approvals will surpass 2007
- Safety fears derail late-stage Amgen cancer trial
- FDA backs Theravance antibiotic, rejects Targanta's
- Credit crunch forces delay at NY biotech complex
- GSK to withdraw, resubmit RLS app; Crestor trial: 'A new age of statins?';
- Tarceva successful as maintenance therapy
- Pfizer follows Sanofi lead, kills obesity program
- Sanofi discontinues clinical trials for Acomplia
- Roche boasts new data supporting Actemra, MabThera
- ZymoGenetics shares plunge after risks halt drug trial
- Nycomed touts pivotal data for COPD drug
- Novartis tracks sustained remission in arthritis study
- FDA extends Pfizer review; Peregrine updates bavituximab data;
- Vertex touts new data; FDA misses Forest Labs' PDUFA date; progress on bird flu vaccine;
- FDA delays approval of AMAG anemia drug
- Daiichi, Lilly: still no word on prasugrel
- Novo Nordisk releases more liraglutide data
- FDA delays review of Takeda's alogliptin
- Genentech issues a "Dear Healthcare Provider" letter re: Raptiva
- Akorn wins FDA OK for topical eye anesthetic
- Merck dumps late-stage obesity drug
- Wyeth, ALS ink marketing deal
- Pfizer drops heart research in R&D revamp
- A.P. Pharma sees positive data in late-stage chemo study
- FDA again delays prasugrel decision
- Deadline clock running on Lilly's next big blockbuster
- FDA delays Roche's blockbuster Actemra
- Inhaled insulin shows signs of life after setbacks
- Amgen shares surge on positive D-mab data
- Allergan says data supports Botox for migraines
- Study: Biotech patent system broken
- Pfizer withdraws dalbavancin app
- BMS, AstraZeneca present saxagliptin data
- Panel backs Pfizer's Fablyn, with caution
- Pfizer's Fablyn may be linked to more deaths
- Regeneron's Arcalyst a success in Phase II
- Peplin gains $24M to fund Phase III
- FDA approval drought hit as apps surged
- Azilect data points to Parkinson's efficacy
- Study questions Gardasil's payback
- FDA wants more information on Doribax
- Rheumatology: fastest growing subject of trials
- FDA OK's first drug for Huntington's disease
- Small biotech campaigns for biogenerics law
- Sanofi-Aventis wins priority review for Multaq
- FDA still hush-hush on drug rejections
- Drought of approvals gets worse for developers
- Researchers herald breakthrough data on Alzheimer's
- Developers advancing a new slate of weight loss drugs
- FDA staffers say Actemra works against RA
- Vanda shares swoon after FDA rejects therapy
- EMEA issues host of decisions
- No Nplate decision today; Silence shares rise on patent award;
- Will Roche/Genentech team create industry model?
- FDA expected to act soon on Amgen’s Nplate
- Feds halt HIV vaccine human trial in latest setback
- Dimebon shows positive data in Alzheimer’s study
- Optimer announces postive Phase II data
- New direction for Alzheimer's research?
- Introgen shares dive after report questions drug’s efficacy
- Merck's cholesterol drug wins European OK
- ViroPharma to buy Lev for $442M
- Minnesota blueprints new complex for biomedical research
- Alcon axes eye program
- GSK inks $3.25B insomnia pact with Actelion
- In fresh blow, Roche shutters HIV research program
- Amgen releases positive denosumab results
- Side effects force Neurogen to suspend dosing
- Repros data highlights pain relief in Proellex trial
- Pharming shares spike on positive Rhucin data
- FDA goes neutral with new response letters
- Schering-Plough fertility drug aces Phase III
- Invitrogen gets breast cancer test approval
- Medivation touts Phase II data on Huntington’s therapy
- Copaxone disappoints at higher dose
- Introgen axes staff as focus shifts to commercialization
- Amgen drug positive in cancer trial
- FDA panel backs added risk review on diabetes drugs
- Three technologies that could change the world
- Introgen files first gene therapy for FDA approval
- UCB files for Cimzia RA approval in Europe
- Positive data paves way for ThromboGenics trial
- Biopharma sees tougher FDA approval process
- Labopharm hopes high for tramadol despite rejection
- Flurizan flunks its Phase III Alzheimer’s test
- Merck, Schering-Plough end respiratory collaboration
- Ardea touts IIa data
- Quark prepares for human trials of siRNA therapy
- FDA considers new trial standard for diabetes drugs
- FDA delays review of Eli Lilly’s would-be blockbuster
- GTC shares jump on $257M ATryn pact
- AtheroGenics releases diabetes data
- FDA lifts clinical hold on YM therapy
- Discovery Labs shares dive on FDA delay
- Australia approves bird flu vaccine
- Phase III data paves way for Theratechnologies’ NDA
- FDA committee backs Centocor psoriasis drug
- Alzheimer's vaccine results boost Elan, Wyeth
- Scientists lament HIPAA's impact on new research projects
- Biotech drug sales grow 12.5% in 2007
- J&J psoriasis drug may carry cancer risk
- Sanofi: Acomplia demonstrates better glucose control
- Hollis-Eden touts new diabetes data; Nastech announces positive insulin report
- Vertex shares rise on positive data for telaprevir
- DPP-4 inhibitors get spotlight at ADA meeting
- Committee votes to back GSK/Ligand's Promacta
- Bayer, J&J tout rivaroxaban data
- SPOTLIGHT: Pertuzumab slows breast cancer in study
- Alfacell stock takes a hit on Onconase data
- Expert panel underwhelmed by GSK's Promacta
- Merck's osteoporosis drug performs in Phase II
- Amgen's D-mab beats Fosamax in trial
- United posts positive data for inhaled PAH drug
- Wyeth gets approvable letter for bazedoxifene
- Progenics, Wyeth drug fails late-stage trial
- Merck shelves study of cholesterol drug
- Aflibercept misses endpoint in mid-stage study
- FDA OKs Adolor's Entereg in first approval
- Ipsen clears FDA hurdle, gains $25M for Reloxin BLA
- FDA picking up the pace on '08 approvals
- Roche posts new data backing Actemra for RA
- Talecris' antibody drug gets priority review
- FDA delays Entereg decision
- FDA approves Lilly's ADHD drug Strattera
- Analyst predicts a long delay for Merck's Cordaptive