As we settle in to 2019, FierceMedTech has provided its list of the top 2018 BioTech companies. The companies are: 10x Genomics, AblaCare, Allevi, Ceribell, Evidation Health, FineHeart, Glympse Bio, Invizius, Mekonos, Mindstrong Health, Pear Therapeutics, Potrero Medical, Profusa, Sana Health and Spry Health.
Takeda has met its goal in an ongoing Phase 3 study that covers eight countries and has enrolled more than 20,000 participants. The study, of Takeda’s shot to prevent dengue, prevented infections with four different serotypes of the virus. More results due out later this year.
The FDA has approved Abbott’s Amplatzer Piccolo Occluder which is being described as the world’s first implant designed for babies weighing as little as two pounds.
This device, which is smaller than a pea, is used to treat patent ductus arteriosus, the most common congenital heart defect in premature babies.
After receiving FDA last month for its prescription software to treat opioid addiction, Pear Therapeutics has posted $64 million in new fundraising.
The reSET-O prescription digital therapeutic for opioid use disorder consists of a 12-week cognitive behavioral therapy program along with outpatient treatment. It includes buprenorphine, a standard medication for opioid addiction, while helping to reinforce positive behaviors through interactive therapy lessons…
Lilly has confirmed that it will acquire targeted cancer drug maker Loxo Oncology for $8 billion. This will give the Indianapolis based company the TRK inhibitor Vitrakvi, the first drug approved by the FDA to target tumors according to a genetic abnormality rather than the location of the cancer.
This comes just days after Bristol-Myers Squibb announced its $74 billion acquisition of Celgene.
It has taken about a year, but GlaxoSmithKline and Pfizer have agreed to an all-equity transaction that will combine their consumer units that will eventually be spun off to create to new company. The company will be under GSK’s name and have a market share that is 7.3% ahead of its competitors, Johnson & Johnson, Sanofi and Bayer.
A smartphone app designed by Pear Therapeutics has received FDA clearance for treating patients suffering from opioid abuse. This is the first prescription digital therapeutic to treat opioid addiction to be cleared by the FDA.
The app will be used in conjunction with standard outpatient…
Bayer announced last week that it will close its hemophilia manufacturing facility in Wuppertal, Germany, and lay off 350 workers. Its recombinant factor VIII production will take place at its site in Berkeley, California. The cuts in Germany come on top of the announced layoffs in October of more than 225 manufacturing workers in Berkeley.
The FDA has extended the patent for Pfizer’s top selling drug, Lyrica, which was set to expire at the end of this year. The company now has exclusivity until June 30, 2019. With Lyrica sales reaching nearly $3.5 billion in the US in 2017, this extension will allow Pfizer to protect about half of that figure next year.
Pfizer has announced that as of January 2019 it will be raising prices on 41 of its drugs. Thirty-seven will increase by 5%, three by 3% and one by 9%. In total, these drugs represent about 10% of Pfizer’s portfolio. These increases follow similar increases this past summer to about the same number of drugs.
The first of a series of recalls involving blood pressure medication were in August. Months later, tainted drugs continue to be found in the US supply. The FDA and Sandoz have announced the recall of one lot of losartain blood pressure medicine that was manufactured by its Lek Pharmaceuticals unit in Ljubljana, Slovenia, because it contains N-nitrosodiethylamine (NDEA), a suspected carcinogen.
NDEA along with N-Nitrosodimethylamine (NDMA) are two probable human carcinogens that the FDA has discovered can be created during manufacturing under certain conditions.
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The third quarter US sales for Regeneron’s Eylea were listed as $1.02 billion. This is the first time the drug has generated over $1 billion in quarterly US sales. Q2 sales were $992 million. In August, Eylea received an FDA nod in wet age-related macular degeneration as a 12-week dosing formulation, and the agency is scheduled to decide on the drug’s use in diabetic retinopathy by May 13, 2019.
Glenmark was one of a number of drugmakers that have decided to build US manufacturing plants due to FDA restrictions on facilities in India that was keeping them from exporting to the US. Glenbrook, a Mumbai-based generics company plans to open its $100 million plant today in North Carolina.
Pfizer and Bain Capital have teamed up to form a new biotech, Cerevel Theracpeutics. The company will focus on development drug candidates to treat disorders of the central nervous system. Prizer is contributing a portfolio of pre-commercial neuroscience assets and Bain Capital is providing #350 million in capital.
Teva has lost its appeal to maintain several patents on its 40 mg version of its multiple sclerosis drug Copaxone.
The drug is a key sales contributor for Teva. Sales of the short-acting version of the drug have plummeted with Mylan and Novartis generics out there. Sales for the 20mg and 40mg versions together amounted to $940 million in North America…
Insmed’s Arikayce has become the first drug approved under a novel FDA pathway designed to speed development of antibiotics.
The active component of antibiotic Arikayce is amikacin, a decade-old antibiotic that’s on the WHO’s essential drug list. But instead of administering it intravenously, Insmed created an…
Big Pharma is expected to get much bigger over the next several years, with the companies competing to grow their sales in a list of established and emerging therapeutic areas, notably cancer and immunology.
Regeneron is planning a build out of its second campus in Rensselaer, New York. The plan includes adding manufacturing capacity, laboratory space and warehouse facilities. With the expansion, Regeneron will be 1,500 jobs over the next seven years and receiving $140 million in tax incentives from the state.
AstraZeneca’s severe asthma drug, tezepelumab, has received breakthrough therapy designation from the FDA. Tezepelumab treats a broader respiratory population than AZ’s FasenraIt which could help boost the company in its battle with GlaxoSmithKline.
Otsuka’s Abilify MyCite, the only FDA-approved digital pill, has taken another step toward patients thanks to a deal with Magellan Health to distribute the medicine through its network of mental health providers.