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Pfizer’s ADC ambition bolstered by US Besponsa approval

23-Aug-2017 - Pfizer has been granted US approval for its antibody-drug conjugate (ADC) Besponsa, to be manufactured at the firm’s Pearl River, New York facility.

Samsung Bioepis teams with Takeda to take first steps into novel biologics space

22-Aug-2017 - Samsung Bioepis says it will continue focusing on biosimilars as it ventures into the innovative biologics space through a partnership with Takeda.

EMA plans biomarker and drug-matched guidelines

17-Aug-2017 - The European Medicines Agency (EMA) is working on guidelines to help drug firms to develop companion diagnostics in parallel with medicines.

EMA bids to clarify API starting material info pharmas should provide

16-Aug-2017 - The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.

Avara agrees to buy ex-Hospira plant in Italy from Pfizer

10-Aug-2017 - Avara Pharmaceutical Services has agreed to buy Pfizer Inc. sterile drug manufacturing facility in Liscate, Italy.

update

Pfizer chooses Sanford, North Carolina site for $100m gene therapy plant

09-Aug-2017 - Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.

US FDA clarifies what constitutes 'minor' change to biologic production process

09-Aug-2017 - The US FDA has sought to clarify when biologics firms should inform it about minor changes to manufacturing processes in draft guidance this week.

update

Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access

08-Aug-2017 - Public Health England has reserved NHS hepatitis B vaccine stocks for people at high risk of infection, citing shortages caused by production interruptions at Merck & Co and GSK....

US FDA finds faults at Biocon plant slammed by French regulators in July

07-Aug-2017 - The US FDA has issued Biocon with a Form 483 detailing problems inspectors identified at a plant in Bangalore, India.

Biosimilar boost for Pfizer but Inflectra takes just 2.3% of US infliximab market

04-Aug-2017 - Pfizer saw a 60% year-on-year growth in sales from its biosimilar products but Inflectra penetration in the US was lower than expected.

Teva and Amgen latest to submit trastuzumab biosimilars to US FDA for review

01-Aug-2017 - The US FDA has accepted submission of two further Herceptin (trastuzumab) biosimilars: ABP 980 developed by Amgen and Allergan, and Teva and Celltrion’s CT-P6.

Roche offsetting biosimilar competition with 16 breakthrough therapies

28-Jul-2017 - Roche is confident its biologics pipeline and plan to reformulate some of its top selling monoclonal antibodies can offset sales erosion resulting from biosimilar competition.

Discount dancers: Pfizer's infliximab matching Merck’s new biosimilar rival

26-Jul-2017 - Pfizer dropped the US price of Inflectra, its version of Johnson & Johnson's Remicade, just weeks before Merck & Co. launched its infliximab biosimilar, Renflexis.

Exclusive interview with CEO TH Kim

Samsung Biologics: Reducing COGS could double mammalian CMO use to 50%

25-Jul-2017 - Samsung Biologics wants Big Pharma to up biomanufacturing outsourcing and says lessons learned from the semiconductor industry will give it the advantage in the CMO space.

News in brief

US FDA gives thumbs up to Avastin and Herceptin biosimilars

25-Jul-2017 - Amgen and Mylan have both received recommendations for their versions of Roche’s monoclonal antibody blockbusters Avastin and Herceptin.

Second US infliximab biosimilar launched at 35% discount to J&J’s Remicade

25-Jul-2017 - Merck & Co. will challenge both reference drugmaker J&J and fellow biosimilar developer Pfizer through its version of Remicade, Renflexis.

Cancer-fighting combo: mRNA and antibody-focused treatment wins EU patent

21-Jul-2017 - Regulators have granted CureVac a European patent for its mRNA vaccine and anti-PD-1 antibody technology designed to prevent and treat cancers and infectious diseases.

Sanofi signs nanobody drug and tech deal that could earn Ablynx billions

21-Jul-2017 - Sanofi has licensed access to Ablynx NV’s nanobody platform as well as candidate drugs in a deal that could earn the Belgian firm billions of euros.

update - comment from Unite

GSK says UK manufacturing cuts not Brexit related

20-Jul-2017 - GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and...

Update - comments from EMA and EFPIA

EU to probe if drug firms' pre-submission meetings sway EMA approval decisions

19-Jul-2017 - Drug firms’ pre-submission meetings with the EMA may influence agency approval decisions according to European Ombudsman Emily O' Reilly who has launched an investigation 

Proliant BSA in Asia: China opens door to NZ bovine blood

19-Jul-2017 - Following months of importation restrictions, Proliant Biologicals has announced it is eligible to export bovine serum albumin (BSA) from its Feilding, New Zealand-based facility to China.

US FDA to decide on Spark's vision loss gene therapy Luxturna in January

18-Jul-2017 - The US FDA has promised to review Spark Therapeutics’ candidate vision loss gene therapy Luxturna by next January.

Emergent to buy Sanofi smallpox vaccine and take on CDC contract

18-Jul-2017 - Emergent BioSolutions will pay up to $125m (€108m) for Sanofi’s smallpox vaccine ACAM2000 in a deal that includes a plant and 10-year supply contract with the US Government.

GE Healthcare and Oritain launch testing service to combat serum fraud

12-Jul-2017 - Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.

Sanofi shells out $650m for non-egg based vaccine maker Protein Sciences

11-Jul-2017 - Sanofi will add the recombinant protein-based influenza vaccine Flublok to its products, along with a manufacturing facility in Pearl River, New York.

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