- Ibuprofen gels not a patch on new delivery tech say UK developers (in-pharmatechnologist.com)
UK researchers have developed an ibuprofen patch they claim offers better dosage control than gel formulations of the pain drug…The patch – which was developed by researchers at the University of Warwick and spinout company Medherant – consists of a transparent layer that is stuck to the skin with an adhesive polymer into which…in this case ibuprofen - is incorporated… the approach enables precise dosage control because the patches have “a defined size with a set amount of drug.”…the technology has wider application…“We know that a lot of other APIs can be incorporated in our patches”…Medherant is interested in partnering with the pharmaceutical industry.
- China economy not the main culprit in pharma slowdown, FT says (fiercepharmaasia.com)
If drugmakers foreign and domestic are counting on a return to reaping big benefits once China bounces back from its recent economic decline, they may wish to take another look. The economy may not be the problem; it is in the design of the nation's huge healthcare system…That is the conclusion of a lengthy look at the healthcare situation, including pharmaceuticals, in China by London's Financial Times…China has been engaged in a huge expansion of its healthcare system for the past several years, aimed primarily at getting care to all parts of the vast country, primarily its rural parts… while demand was increasing for pharmaceuticals, medical devices and other healthcare items, China needed to rein in the costs of the system and operate it more efficiently…China especially saw a need to get more bang from its $150 billion spent on pharmaceuticals at the same time a new government focused on ending corruption, which in healthcare centered on a hospital system that relied on drug sales for adequate income…“the whole health system is unbalanced,"…
- India a potential center for orphan drug development and demand (fiercepharmaasia.com)
India may be sitting on a pharmaceutical gold mine. It has more than 7 times the number of people affected by rare diseases than the United States, a less expensive workforce for making drugs and an often-criticized price-control system that, by definition, does not affect orphan drugs…One India-based company sees a profitable outcome for its orphan drug, a sign the nation could become a major source of the often-overlooked treatments as other drugmakers watch to see if the optimism is justified and lasts… India offers the advantage of cheaper drug development, orphan drugs often have already produced or at least studied relatives, and many of them…are curative, thus reducing the burden on healthcare systems. And, it has a lot more potential patients.
- Pfizer-Allergan Merger Raises Concerns That Fraud Is Part Of ‘Corporate DNA’ (forbes.com)
The massive Pfizer-Allergan merger is getting a lot of attention. It is one of the largest takeovers ever in the healthcare industry, worth an estimated $160 billion…But consider another number: The amount Pfizer, Allergan and their predecessor companies have paid to settle government healthcare fraud allegations in the US – a total of nearly $4.5 billion. That total doesn’t include close to $1 billion paid to settle related consumer actions…Add to that the six criminal pleas and four corporate integrity agreements that the companies and their predecessor subsidiaries have agreed to, and one might question whether cheating and corruption are part of their “corporate DNA.”… The duo’s “hall of shame” is staggering and impossible to overlook. Here are some of the settlements the two corporations and/or their predecessor companies have paid the US and states:
- Pfizer/Parke Davis/Warner Lambert — $430 million settlement and a criminal plea. (2004)
- Pfizer/Pharmacia & Upjohn Co. — $2.3 billion and a criminal plea. (2009)
- Allergan — $600 million and a criminal plea. (2010)
- (Allergan/Actavis) Forest Labs — $313 million and a criminal plea. (2010)
- Pfizer — $14.5 million. (2011)
- (Allergan/Actavis) Watson Pharmaceuticals — $1.7 million. (2012)
- Pfizer/Wyeth Pharmaceuticals — $491 million and a criminal plea. (2013)
- Allergan/Actavis/Watson Pharmaceuticals — $12.4 million. (2013)
- Pfizer/Wyeth — $35 million. (2014)
- Allergan/Warner Chilcott — $125 million and a criminal plea. (2015)
- Reefer Gladness? DEA OKs Catalent to supply marijuana from Missouri plant (in-pharmatechnologist.com)
Catalent has registered a facility in Missouri with the DEA to import cannabis extracts in dosage form for clinical trial studies…The contract development and manufacturing organisation applied for its Kansas City...site to be registered as an importer of controlled substances in August, and last week the Drug Enforcement Administration approved the request…“[Catalent Pharma Solutions] is granted registration as an importer of marihuana, a basic class of controlled substance listed in schedule I,”…“The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies.”..One of Catalent’s customers is GW Pharmaceuticals which has a marijuana-based compound, Epidiolex (cannabidiol), in Phase III trials for the treatment of Lennox-Gastaut syndrome…The company ships finished product to a storage facility run by Catalant in the US and investigators draw material from that facility,”
- Sanofi, Shantha to supply polio vaccines for India’s universal immunization scheme (fiercevaccines.com)
India will join more than 110 countries that have introduced the injectable inactivated polio vaccine to their calendars. Sanofi and its Indian affiliate, Shantha Biotechnics, will supply polio vaccines to the Indian government via UNICEF. The vaccines will be used in India's universal immunization program…Sanofi Pasteur has already supplied the government with its Imovax Polio vaccine, and Shantha will soon follow suit with its ShanIPV. While oral polio vaccines have previously been included in the nation's universal immunization program, the WHO recommends replacing it with the injected inactivated vaccine…While India is officially polio-free, it borders Pakistan and Afghanistan, which still report polio cases…With the introduction of IPV in their immunization schedule, India moves the world much closer to being polio-free…
- China toughens drug quality standards, rejects 13 applications (reuters.com)
China's food and drug regulator said late on Monday it had rejected applications for 13 new drugs, citing false or incomplete trial data, as the government toughens enforcement of quality standards…China Food and Drug Administration last month also rejected applications by eight Chinese companies for inadequate trial data related to generic drugs for heart problems, schizophrenia, pain, infections and other diseases…quality of locally made drugs is a priority for the government, which is pushing an ambitious program of healthcare reforms to reduce reliance on both generic and more innovative imported drugs.
- Biotech firm settles insider trading lawsuit for $20M (statnews.com)
More than a year after denying allegations it surreptitiously attempted to boost its stock price, Galena Biopharma has agreed to pay $20 million to settle a shareholder lawsuit that accused the drug maker of a misleading marketing campaign and insider trading…The settlement resolves an unusual episode that raised questions about the extent to which some biotech companies may have been aggressively promoting their prospects during a bull market in biopharma stocks. However, we should note that Galena and its executives and directors did not admit any wrongdoing…Galena said it “believes the claims are without merit, but is settling the lawsuits to avoid potentially lengthy, costly, distracting, and time-consuming litigation.” Of the $20 million payment, $16.7 million will be paid by the company’s insurers and $3.3 million will be paid by Galena — $2.3 million in cash and $1 million in stock. This represents less than 1 percent of its outstanding shares.
- Pozen and Tribute, spooked by tax rule changes, kill plans to put merged company in Ireland (fiercepharma.com)
The U.S. Treasury's latest stab at deflecting tax inversions deals has persuaded at least one player to give up plans for a move to Ireland, but not from looking outside the U.S. for some tax relief. Pozen, which was headed to Ireland as part of its merger plans with Tribute Pharmaceuticals, will set up shop instead in Tribute's home turf of Canada…The two drugmakers said recently they charted the change of course "after reviewing the recent guidance from the Treasury's Notice 2015-79 issued on November 19, 2015 and its potential impact on the proposed transaction."…Pozen and Tribute recommitted to their merger but said that they will go to Canada instead…The new company, which will be renamed Aralez Pharmaceuticals, has a $350 million commitment from a syndicate led by private equity firm Deerfield Investments.
- Tonix Pharma, U.S. Defense Department partner on PTSD drug (reuters.com)
Tonix Pharmaceuticals Holding Corp said it was teaming up with the U.S. Department of Defense to further develop its experimental PTSD drug, which if approved, could be the first treatment for the psychiatric disorder in more than 15 years…The Cooperative Research and Development Agreement with the Department of Defense will allow Tonix to gain access to and study military personnel who are on active duty…"Since we are specifically seeking a label for military-related PTSD for our drug, it's important to study these patients as the active duty personnel are closer to traumatic events, as opposed to veterans,"… Tonix's TNX-102 is currently being tested in mid-stage studies and has a long path to approval…Some analysts have called the drug a "dark horse" opportunity, which could be transformative for the company…The only two drugs currently approved for PTSD - Zoloft and Paxil - come with substantial side effects. Tonix's drug is intended to improve sleep quality in these patients, which is considered to be a crucial characteristic of the disease.









