Breaking News on Global Pharmaceutical Technology & Manufacturing

APIs (active pharmaceutical ingredients)

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Pfizer cold on Viagra-laced ice cream idea

15-Apr-2014 - Pfizer has reminded the creator of Viagra-flavoured ice cream that the blockbuster erectile dysfunction treatment should only be available on prescription.

Acura pays Pfizer $2m to buy back anti-abuse tech and relaunch Oxecta drug

15-Apr-2014 - Acura has reacquired the rights to its opioid abuse-deterrent technology from Pfizer and is looking for pharma partners to relaunch its oxycodone HCL drug Oxecta.

UPDATE

Sugar in place of APIs discovered in EU's largest fake drug seizure

14-Apr-2014 - Fake aspirin and anti-diarrhoeal medicines were amongst the largest counterfeit drugs haul discovered to be destined for the European Union, a French customs official says.

USCC: making sure Chinese APIs are safe is “hopeless task” for US FDA

14-Apr-2014 - Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.

Canton Labs hit with US FDA Import Alert at Indian API plant

11-Apr-2014 - The US FDA has banned imports of drug products made at Canton Laboratories’ Baroda, India plant weeks after the plant was pulled up for data failures.

Neuland opens new facility in India as part of deal with Japanese company

10-Apr-2014 - CMO Neuland Laboratories has opened a new manufacturing facility in Hyderabad, India as part of its collaboration with Tokyo-based API Corporation (APIC).

Foreign customers look to US FDA as stamp of quality

09-Apr-2014 - Passing US FDA site inspections is vital to attracting international clients, a European API supplier has said.

Mushroom enzymes could work cost saving magic for API makers say researchers

09-Apr-2014 - Fungi have no place in an API facility, but soon enzymes derived from them may be commonplace say scientists developing oxidoreductases for cost and time saving industrial applications.

Pfizer, Novartis developing MenB vaccines to combat new strain

09-Apr-2014 - Recent outbreaks of a strain of meningitis, known as “serogroup B” or “MenB”, on US college campuses have caused both Pfizer and Novartis to develop new vaccines. 

Team culturing cancer APIs says tech can make other plant derived drugs

08-Apr-2014 - Enzyme experts trying to make the anticancer APIs vincristine and vinblastine with engineered cell lines say the technology could be used to produce a wide range of plant-derived drug actives including alkaloids like morphine.

Fiocruz to help make pediatric formulation of bitter schistosomiasis drug

08-Apr-2014 - A consortium developing treatments for children infected by parasitic worms has signed up Brazilian drugmaker Fiocruz as a formulation and manufacturing partner to support upcoming clinical trials.

WHO calls for more industry invesment in tick-borne disease treatments

07-Apr-2014 - Better data on the global burden of tick-borne illnesses may encourage profit driven drugmakers to spend their R&D budgets on much needed treatments says the WHO.

UPDATE

Sun Pharma's $3.2bn Ranbaxy acq: 'Compliance first, synergies later'

07-Apr-2014 - Regulatory compliance will be the number one focus for Sun Pharma, the company says, following its $3.2bn (€2.3bn) takeover of Indian generics firm Ranbaxy.

US FDA issues import alert on Apotex’s Indian API facility

03-Apr-2014 - The US FDA has banned generic drugmaker Apotex from importing drugs made at its plant in Bangalore, India after discovering GMP violations.

Lupin: Mexican buy a bridgehead to generics and API growth

01-Apr-2014 - Lupin has bought Mexican eye drugmaker Grin in a deal that gives it a “bridgehead” to grow its API and generics business in the region.

UPDATE

GSK issues recall after Irish API plant slammed by US FDA Warning Letter

01-Apr-2014 - GlaxoSmithKline has issued a recall of its antidepressant drug Paxil after receiving a US FDA Warning Letter for failing to fully investigate contamination issues at an Irish API plant.

Portable tech advancing fight against counterfeits, says MHRA

01-Apr-2014 - Making API detecting technologies more portable has been a major development in the fight against counterfeit drugs, according to the MHRA, though the biggest threat comes from online sellers.

UPDATE

Goodwin and Aspyrian team to deliver cancer-killing drugs by infrared light

27-Mar-2014 - ADC-makers could avoid using costly cytotoxics in antibody-drug conjugates (ADCs) by using near‐infrared (NIR) light to activate targeted cell-killing payloads, says Goodwin who has team up with Aspyrian Therapeutics.

Indian API maker slammed with US FDA Warning over data issues

25-Mar-2014 - Failure in maintaining test and production data has landed an Indian API maker with a Warning Letter from the US Food and Drug Administration (FDA). 

news from Interphex

Lack of investment in production of low margin drugs behind shortages says expert

24-Mar-2014 - The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.

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