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Headlines > August 2015

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Progress seen In addressing US drug shortages, but challenges remain

31-Aug-2015 - New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US...

Europe bans drugs tested by GVK; FDA monitors but keeps allowing sales

31-Aug-2015 - The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.

FDA opts for four-letter suffix to distinguish biologics and biosimilars

28-Aug-2015 - The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.

Cure not kill: Dynamite ingredient can improve cancer treatment says study

27-Aug-2015 - Nitroglycerin could make cancer drugs more effective say researchers trying to use the dynamite ingredient to help destroy tumours.

To supply the Dane: Novo expects First API batch in 2020

27-Aug-2015 - Novo Nordisk has confirmed it will build an API plant in the US, telling this publication a desire to have manufacturing capacity in the key market for its oral diabetes candidate,...

Scientists build ‘microfish’ robots for controlled drug delivery

27-Aug-2015 - US researchers say 3-D printed microscopic fish robots will allow intelligent drug delivery.

MHRA uncovers $1m illegal ED drug haul

27-Aug-2015 - A UK man has been sentenced to 16 months in prison for smuggling illegal erectile dysfunction drugs following an MHRA investigation.

Europe, US, Japan: The recall round-up

27-Aug-2015 - Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.

Novo Nordisk to pump $2bn into diabetes network on back of oral GLP-1 milestone

27-Aug-2015 - Novo Nordisk could spend up to $2bn (€1.8bn) on two facilities to support its diabetes portfolio, including an oral long-acting GLP-1 analogue set to enter Phase III trials.

MHLW urges Japan's generics sector to consolidate

26-Aug-2015 - The Japanese Government says consolidation of the country’s generics sector is needed to secure supplies.

Device advice: Intertek study shows its key to consider devices in formulation development

26-Aug-2015 - Pharma firms developing inhalable drugs often fail to test that their formulations are compatible with their intended delivery devices early enough according to the Intertek team behind research stressing the...

MHRA launches fees calculator

26-Aug-2015 - The UK regulator is launching a calculator to help pharma companies calculate the fees for drug applications.

DSM says plans to cut 1,100 jobs prompted by recent pharma moves not shareholder pressure

25-Aug-2015 - Royal DSM will make up to 1100 staff redundant by the end of 2017 to cut costs following the formation of its Sinochem JV and pharma products deal with Patheon.

GSK backtracks on Memphis divestment plans, invests $2m

25-Aug-2015 - A GSK facility in Memphis Tennessee which was scheduled to be sold off will now receive $2m to improve its manufacturing infrastructure.

‘Sheer ridiculousness’ or fair play? USPTO turns down patent challenge

25-Aug-2015 - The US Patent and Trademark Office (USPTO) has refused to review a challenge to Acorda Therapeutics’ patents from a group trying to block “abusive” IP claims.

‘Eat or be eaten;’ Mylan says Perrigo could be run as subsidiary

25-Aug-2015 - Mylan will run Perrigo as a wholly-owned subsidiary if it acquires between 50-80% of shares, the firm has clarified.

News in brief

CMO Regis Technologies opens potent API site

25-Aug-2015 - Regis Technologies has opened a site for manufacturing highly potent active pharmaceutical ingredients (HPAPIs) in Illinois.

Google launches life sci unit as standalone Alphabet company

24-Aug-2015 - Google has announced plans to launch its life sciences team as a standalone unit under its new Alphabet structure.

Pfizer’s $17bn Hospira deal set to close in September after US FTC clearance

24-Aug-2015 - Pfizer has received the final regulatory clearances to acquire Hospira but the US FTC says it must divests four sterile injectable products.

News in brief

AmbioPharma expands US manufacturing site and starts work on global HQ

24-Aug-2015 - Peptide maker AmbioPharma will invest $18.8m to expand its manufacturing operations in South Carolina in a move that it claims will create 100 jobs.

US FDA OK with a bit of blue: Colorcon's Spirulina approved for pharma pills

24-Aug-2015 - Drugmakers trying to make blue or green pills for the US market have a new option after the FDA approved a bacteria-derived extract developed by Colorcon for pharma applications. 

UK bioindustry group calls for Government biomedical catalyst scheme to continue

21-Aug-2015 - The UK’s Biomedical Catalyst funding scheme encourages investors to back innovative biopharma research and should be continued according to the BioIndustry Association (BIA).

News in brief

Merck recalls 276,000 pill bottles

20-Aug-2015 - Merck & Co. has recalled two chemotherapy products because of cracked caps, including one it manufactures for Novartis’ Sandoz.

Valeant to buy "female viagra" maker Sprout for $1bn

20-Aug-2015 - Valeant Pharmaceuticals is set to buy Addyi maker Sprout Pharmaceuticals under a $1bn (€895m) deal agreed today.

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