GlaxoSmithKline, AstraZeneca and Johnson & Johnson have joined with three leading British universities to create a new 40 million pounds ($57 million) fund backing early drug research. The Apollo Therapeutics Fund, which aims to improve the speed and potential of university research being translated into new medicines, is a further example of a trend […]
Deal activity is rampant as Big Pharma gobbles up next-generation medicines and technologies to help overcome maturing pipelines and biosimilar threats.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.
Nearly two decades ago, the promise of precision medicine began making its mark on the pages of medical journals – along with speculation that “therapy with the right drug at the right dose in the right patient” – would define the future of medical treatment.
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
January 22, 2016By Alex Keown, BioSpace.com Breaking News Staff PHILADELPHIA – TetraLogic Pharmaceuticals (TLOG) plans to eliminate two-thirds of its employees by next month following the failure of a Phase II treatment for high-risk patients with myelodysplastic syndromes earlier this month. The company filed a regulatory report with the U.S. Securities and Exchange Commission […]
NEW BRUNSWICK, N.J. — Johnson & Johnson (JNJ) has halted a trial of an experimental fatty acid amide hydrolase inhibitor, a drug similar to one being tested in France by a Portuguese pharmaceutical company that left one patient brain dead and five others hospitalized, Reuters reported this morning. A Johnson & Johnson spokesperson told Reuters […]
More than 80 international drug and biotech firms urged governments to work with them to combat drug-resistant superbugs which could kill tens of millions of people within decades unless progress is made and new antibiotics found. In a declaration at the World Economic Forum in Davos, they called for coordinated efforts to cut unnecessary […]
Alkermes Plc said its drug for major depressive disorder did not meet the main goal in two late-stage studies, sending its shares plunging by a third. The drug, ALKS 5461, is the company’s lead product designed to rebalance brain function that is dysregulated in the state of depression. “We believe trial failures present a major […]
Zafgen Inc reported positive data on its obesity drug, which has been marred by two patient deaths, and said the data could help convince the U.S. Food and Drug Administration to allow it to restart trials on the drug. The company’s shares more than doubled on Wednesday on hopes that Zafgen could be allowed to […]
(Reuters Health) – When mothers eat three sizeable servings of fish each week during pregnancy it may benefit children’s brains for years to come, according to a large study in Spain. Researchers followed nearly 2,000 mother-child pairs from the first trimester of pregnancy through the child’s fifth birthday and found improved brain function in the […]
At last week’s J.P. Morgan Healthcare Conference held in San Francisco, Chicago-based AbbVie (ABBV)’s chief executive officer, Richard Gonazalez, presented data in support of the company’s pipeline. The Motley Fool points out that many analysts believe the company depends too much on its anti-inflammatory drug, Humira. Gonzalez’s talk was an effort to show the company […]
The Gavi global alliance for vaccines and immunization group signed a $5 million advance purchase commitment on Wednesday to buy a vaccine being developed by Merck to protect against future outbreaks of the deadly Ebola virus. Gavi said the agreement would help the U.S. drugmaker take the experimental Ebola vaccine through late-stage clinical trials […]
January 19, 2016By Mark Terry, BioSpace.com Breaking News Staff Ardley, N.Y.-based Acorda Therapeutics, Inc. (ACOR) announced today that it plans to acquire Turku, Finland-based Biotie Therapies Corp. (BITI) for approximately $363 million. Acorda focuses on central nervous system disorders, such as multiple sclerosis (MS), spasticity related to MS, spinal cord injury (SCI), brain trauma […]
PHILADELPHIA, Jan. 18 2016 /PRNewswire/ — Antiretroviral therapies (ART) have enabled people with HIV/AIDS to live much longer lives, essentially transforming the disease into a chronic condition. Yet concerns for these patients remain. Up to half of people with HIV on these drug regimens have some sort of cognitive impairment, such as memory loss or problems […]
A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated. The Rennes hospital said in a statement that five other volunteers were in stable condition after they were admitted last week. In total, 90 people took part in the trial of the […]
Eleven Biotherapeutics Inc said its lead eye drug failed in a late-stage trial in treating patients with severe allergic conjunctivitis, sending its shares down 36 percent in after-market trading. The drug, codenamed EBI-005, failed to show statistically significant difference in treating ocular itching, compared with the vehicle arm, the company said on Friday. Eleven Bio […]
One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in France of an experimental medicine from an unnamed drug company, the French Health Ministry said on Friday. The ministry did not say what the medicine was intended to be used for. A […]
MARLBOROUGH, Mass. – Privately-held Theracos, Inc. raised $25 million to fund development of bexagliflozin, an experimental SGLT-2 inhibitor for the treatment of Type 2 diabetes, MedCityNews reported this morning. SGLT2 is an acronym for sodium-glucose linked transporter 2, a membrane protein that acts as a portal for glucose into the cell. SGLT2 inhibitors have been […]
Pfizer Inc aims to drive profits in coming years with more-responsive and easier-to-manufacture new cancer treatments. With its French partner Cellectis, Pfizer is in the early stages of developing new cancer treatments called CAR T cells it says has major medical and manufacturing advantages over similar cell therapies being developed by others. The treatments are […]
SOMERSET, N.J.–(BUSINESS WIRE)–Catalent, Inc. (NYSE:CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products today announced, through its wholly owned subsidiary, Redwood Bioscience, Inc., a research collaboration with Roche to develop next-generation molecules coupling different therapeutic modalities using Catalent’s proprietary SMARTag™ technology. Roche will gain non-exclusive […]
Spark Therapeutics Inc. said its expects to be advancing 10 clinical-stage gene therapy programs by 2018, all fully funded with existing financial resources. The plan, according to Spark CEO and co-founder Jeffrey D. Marrazzo, includes having its first commercial product in the market in 2017 and having two other new gene therapy candidates in late-stage […]
The research chiefs of betrothed drugmakers Pfizer Inc (PFE.N) and Allergan (AGN.N) say the proposed combination of their experimental drugs deserves more credit, including potential blockbuster treatments for schizophrenia and depression. Pfizer agreed in November to buy Botox-maker Allergan for $160 billion in a transaction meant to slash Pfizer’s tax rate and achieve other cost […]
Booming Moderna Eyes Six Human Trials in 2016, Inks Deals with AstraZeneca PLC, Merck & Co. and Signed Huge Lease in Cambridge for R&D Growth
First Phase I study underway in Europe for mRNA 1440; IND for second program, mRNA 1851, filed with the U.S. FDA Ecosystem of ventures and partners saw significant growth in 2015, propelling rapid expansion of pipeline spanning multiple mRNA-based drug modalities and therapeutic areas 2016 goals focused on advancing multiple clinical trials, fueling continuing early […]