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Headlines > February 2017

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Bio CDMO space: Fujifilm looking to challenge Lonza and B-I

28-Feb-2017 - Fujifilm has separated its biopharmaceutical contracting business in an effort to triple its revenues to ¥100bn ($890m) within seven years.

Titan puts Parkinson's disease implant trial on hold after FDA asks for more data

28-Feb-2017 - Titan Pharmaceuticals has put plans for a trial of its candidate Parkinson’s disease implant ropinirole after the US FDA asked for additional information.

GSK seeks advice on planned Scottish respiratory API plant

28-Feb-2017 - GSK has asked Angus Council for advice as it prepares to submit a planning application for an API plant it intends to build at its site in Montrose, Scotland.

Looking to gain a foothold in Ireland? MSD puts shuttered site up for sale

28-Feb-2017 - Merck & Co. has put an Irish small molecule plant up for sale after ceasing production late last year.

Pharma Outsourcing & Partnership Global Congress 2017 Europe

Vital statistics? Big Pharma undervaluing commercial data, expert

27-Feb-2017 - Data is a core competence for Big Pharma that should not be outsourced, according to an industry statistics expert.

GSK: Costa Rican Panadol plant closure will eliminate 60 jobs

27-Feb-2017 - GSK says the closing of its Costa Rica manufacturing facility is necessary to ensure the long-term viability of its consumer healthcare business.

Dr. Reddy's' Miryalaguda plant issued with Form 483 after US FDA audit

23-Feb-2017 - Dr Reddy’s Laboratories has been issued with a Form 483 after an inspection at its active pharmaceutical ingredient (API) plant in Miryalaguda in Telangana, India.

Biolabex's Mauritius R&D lab open for business

23-Feb-2017 - Biolabex has opened a manufacturing and R&D laboratory at BioPark Mauritius, a biohub in Vacoas-Phoenix south of the capital Port Louis.

Ohr Pharmaceutical Inc. shuts sustained release tech lab

23-Feb-2017 - Ohr Pharmaceutical Inc. has halted activities at the laboratory in San Diego, California where research on its sustained release delivery technology was carried out.

Gov’t delay could postpone ClinicalTrials.gov usability, patient recruitment

23-Feb-2017 - Several organizations have penned an open letter to NIH urging it adhere to 21st Century Cures deadlines that if missed, will affect improvements to ClinicalTrials.gov – and ultimately, study start...

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.

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...

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. 

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.

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