Chinese API makers look to move up the value chain
05 October 2016
China’s pharma industry is best known for being the low-cost generic API producer to the world. But companies there, large and small, are looking for ways to move up the value chain, including doing deals targeted at the U.S. market.
A pair of biotech IPOs line up: Myovant and Ra Pharma
04 October 2016
The fall IPO filings are ramping up with two biotechs lining up to go out. These include an up to $172.5 million offering for the recently formed women’s health player Myovant Sciences and an up to $86.3 million IPO for rare disease company Ra Pharmaceuticals. The former is aiming for a NYSE listing, while the latter is slated for the Nasdaq.
Market for overdose fixes tied up as epidemic rages: analyst
30 September 2016
Prescription Opioid and Heroin Epidemic Awareness Week closed Friday, but intense talks around the topic and related drug development haven't stopped – and probably won't anytime soon.
In China, when the going gets tough, the tough go local
30 September 2016
Increasingly in China, innovation is meant to be a local game to create local champions, and foreign firms are lining up to find ways to be a part of the action, both big and small.
Drug pricing system broken: Where do we go from here?
30 September 2016
When it comes to how drugs are priced in the U.S., everyone seems to agree on one thing: The system is broken. But before they can fix it, Congress and policymakers need to first understand how it is structured now and where the problems are. The trouble is, they don't know that they don't get it. That much was clear in a House oversight hearing Wednesday on the pricing of Mylan NV's Epipen (epinephrine), which was a missed opportunity to shed some light on a very murky subject.
Ganaxolone Reduces Seizures in Females with PCDH19 Pediatric Epilepsy
29 September 2016
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative therapeutics to treat epilepsy and neuropsychiatric disorders, today announced top-line results from a Phase 2 exploratory open-label clinical trial evaluating ganaxolone, its CNS-selective GABAA modulator, in females with PCDH19 pediatric epilepsy. In the trial, ganaxolone reduced seizure frequency from baseline in the majority of patients enrolled in the study and was generally safe and well tolerated. PCDH19 pediatric epilepsy is a rare, serious epilepsy characterized by early-onset cluster seizures, cognitive and sensory impairment, and behavioral disturbances, with no approved treatments. In 2015, the U.S. Food and Drug Administration granted Orphan Drug Designation to ganaxolone for the treatment of PCDH19.
US and Europe Collaborate on Treatment of Rare Diseases
28 September 2016
The European Medicines Agency (EMA) announced on Sept. 26, 2016 that the EMA/FDA cluster, or working group, on the treatment of rare diseases had its first meeting on Sept. 23, 2016. The cluster was created to share best practices between the US and EU agencies and “provide a forum for confidential exchange of draft documents, policies under development, and more detailed information supporting the scientific basis for decision making on medicine development,” according to an EMA press release.
Pfizer Decides to Remain One Company
28 September 2016
On Monday Sept. 26, 2016, Pfizer announced its decision to remain as one company. The company had been debating whether or not to divide Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies. On Monday, leadership decided against this strategy noting Pfizer is best positioned to maximize shareholder value in its current state.
Separating hope from hype in the latest cancer treatment ‘revolution’
28 September 2016
There’s new hope that a much-hyped class of immunotherapies could revolutionize cancer treatment: Data released this week from an early test on patients stirred hope that the first such therapy could hit the market soon. But experts remain cautious about safety and efficacy — and warn that big questions remain.
For Pfizer, Bigger as One May Be Better Than Smaller With Two
27 September 2016
By deciding not to split in two after a lengthy evaluation, the New York-based drugmaker is keeping greater leverage with the health insurers and pharmacy benefit managers that have gained increasing power since it first considered a breakup years ago.
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NovaMedica team wishes you a Merry Christmas and a Happy New Year!
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