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Headlines > February 2017

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Modus raises cash for Ph II trial of Sickle Cell drug in EU, Middle East and Caribbean

22-Feb-2017 - Modus Therapeutics AB has raised an additional 32m SEK (£2.85m) for its Phase II trial for pain crises in Sickle Cell Disease, running in the Caribbean, Middle East and Europe.

Momenta says Pfizer will fix plant but reiterates that Glatopa 40mg ANDA delay likely

22-Feb-2017 - Momenta Pharmaceuticals has reiterated its belief that problems at a US Pfizer plant mean the FDA is unlikely to reach a decision on its 40mg version of Teva’s Copaxone before...

Opinion

Raging bull' - Vaccines don’t cause autism and saying otherwise costs lives

22-Feb-2017 - Vaccines do not cause autism and people who say otherwise are wrong.

AmpTec looking to achieve full GMP compliance for APIs

21-Feb-2017 - AmpTec GmbH is in the process of achieving full GMP compliance for API manufacturers in order to expand its offerings into the clinical space.

Cancer drug plant likely source of radio isotope detected across Europe say experts

21-Feb-2017 - A radiopharmaceuticals plant is the most likely source of the radioactive iodine-131 detected in several countries in recent weeks according to experts.

Granules to expand Indian API plants and US dosage form site

21-Feb-2017 - Granules India will build an API production facility in Bonthapally, Telangana and expand other manufacturing sites in a project backed by the Word Bank. 

News in brief

Takeda pulls Danish paracetamol batch after two packs found to contain ibuprofen

20-Feb-2017 - Takada Pharma A/S has recalled a batch of its Pamol paracetamol tablets in Denmark after two packs were found to contain ibuprofen.

CMOs need to increase awareness of offerings, ISR reports

20-Feb-2017 - A "new set of leaders" emerged in the contract manufacturing organization (CMO) industry over the past year, though many remain unheard of, according to a recent report .

Tilray begins shipping medical marijuana to more countries

20-Feb-2017 - Medical marijuana developer Tilray has begun shipping to overseas patients and trial sites outside Canada after partnering with local distributors to comply with regional regulations.

Pfizer hit with US FDA warning at Kansas generic Copaxone site

20-Feb-2017 - The US FDA has issued a warning letter to the former Hospira fill and finish facility in McPherson, Kansas – now part of Pfizer’s contract manufacturing business CentreOne.

Tilray grows capacity in North America's only GMP cannabis facility

16-Feb-2017 - Medical cannabis supplier Tilray has expanded its formulary team and mooted the idea of extending its distribution network just weeks after the EMA granted its Canadian production site GMP accreditation.

Is the return of the one-stop-shop model just a CMO marketing ploy?

16-Feb-2017 - End-to end service offerings are a differentiator within the fragmented CMO industry and not driven by pharma demand, a Results Healthcare report says.

Dr. Reddy's Laboratories continues European hospital market expansion

16-Feb-2017 - Dr. Reddy’s Laboratories Ltd has said it may invest in additional manufacturing capacity to support its efforts to grow in the European hospital drug market.

Teva sees higher active pharmaceutical ingredient sales in 2016

15-Feb-2017 - Copaxone maker Teva Pharmaceutical Industries Ltd. saw higher active pharmaceutical ingredient (API) sales last year.

Quotient buys QS Pharma in latest US expansion move

15-Feb-2017 - Quotient Clinical Ltd. has bought Charles River Laboratories’ contract manufacturing business, QS Pharma LLC.

News in brief

Sun Pharmaceutical Industries sees API sales slide in Q3

15-Feb-2017 - Sun Pharmaceutical Industries Ltd. saw lower active pharmaceutical ingredient (API) revenue in the third quarter of fiscal 2017.

US FDA says Japanese OTC firm Sato must do more to fix plant problems

15-Feb-2017 - The US FDA says Sato Pharmaceutical Co., Ltd. has not addressed environmental monitoring shortcomings at its Tokyo plant.

Stada confirms €3.5bn bid from Cinven and interest from Advent

14-Feb-2017 - API manufacturer Stada Arzeneimittel AG has received an acquisition offer from private equity firm Cinven Ltd., and an expression of interest from Advent International Corp.

Indian API maker slammed by US FDA for water and cleaning issues

14-Feb-2017 - The US FDA has issued a warning letter to Indian API maker Resonance Laboratories Private Limited citing inadequate cleaning procedures at its facility in Bangalore.

Thermo Fisher bags single-use bioreactor tech partner Finesse

14-Feb-2017 - Thermo Fisher Scientific says it is buying Finesse Solutions, its long-term supplier of measurement and control solutions for bioprocessing applications.

Symbiosis opens US sales office citing demand from resurgent biotechs

13-Feb-2017 - Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.

GSK on America First: US will not be able to own every part of supply chain

13-Feb-2017 - GSK has warned that Donald Trump’s plan to encourage US drug production through import tax hikes must take the global nature of pharma supply chains into account.

Atlas to invest in extra capacity at STI test manufacturing partner Bespak

13-Feb-2017 - Atlas Genetics has said it will expand manufacturing capacity for cartridge-based STI tests at a UK facility owned by drug delivery technology firm Bespak Europe ltd.

India asks drug firms to help discourage off-prescription antibiotic sales

13-Feb-2017 - Indian regulators want manufacturers to discourage pharmacists from selling antibiotics to patients without prescriptions as part of an effort to curb the spread of superbugs.

Pfizer to shut Australian Neulasta biosimilar plant and move production to Croatia

10-Feb-2017 - Pfizer will close the Australian plant which produces the API for HSP-130, a candidate version of Amgen’s Neulasta, and shift production to Croatia.

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