Heat Biologics cuts patients in clinical trial, workforce

07-Apr-2016 - Heat Biologics has announced several "necessary" but "incredibly difficult" cost cutting measures, including a workforce reduction of approximately 22%.

QPS collaborates to advance biologics bioanalysis solution

07-Apr-2016 - The new collaboration aims to advance a workflow solution for biologics quantification.

Daiichi Sankyo: looming Benicar patent loss and large molecule focus prompted plant closure

06-Apr-2016 - Closure of its Benicar intermediates plant was prompted by impending US patent loss and a decision to focus on large molecule drugs says Daiichi Sankyo.

Samsung Bioepis receives positive EMA opinion for Remicade biosimilar

01-Apr-2016 - An EMA committee has recommended the approval of Samsung Bioepis’ Flixabi, a biosimilar of Janssen’s Remicade (infliximab).

Biocad ships Herceptin biosimilar to Sri Lanka

30-Mar-2016 - Biocad has begun supplying its biosimilar version of Roche’s Herceptin (trastuzumab) to breast cancer patients in Sri Lanka.

New WCG board to advise on gene therapy research

30-Mar-2016 - WIRB-Copernicus Group (WCG) has assembled a team of experts to advise the company as it advances its gene therapy research. 

Real-world biosimilar data driving physician acceptance, says Celltrion

30-Mar-2016 - Biosimilar acceptance among physicians has doubled to 80% since 2013, according to a survey presented at by copycat biologic distributor Celltrion Healthcare.

Eiger sanctioned: Celladon shareholders agree merger

25-Mar-2016 - Eiger Biopharmaceuticals has merged with what is left of gene therapy developer Celladon in a deal that will see the combined firm list on the NASDAQ.

Korea stock? Celltrion stores Remicade biosimilar but minimises risks

22-Mar-2016 - Celltrion’s supply chain and warehousing procedures ensure the safe storage of Remicade biosimilars as demand fluctuates across markets, the drugmaker says.

Lonza: More pharmas among top customers in 2015; Strong franc could erode Swiss industry

22-Mar-2016 - Drug companies were a more important source of revenue for Lonza in 2015 than in previous years with four of its five biggest spending customers coming from the pharmaceutical sector.

Samsung Bioepis says Eli Lilly visit was a courtesy meeting

18-Mar-2016 - Samsung Bioepis has denied it is about to do a biosimilars deal with Eli Lilly after the US drug firm visited its headquarters in Korea.

Dr Reddy's teams with API firm TR-Pharma to launch biosimilars in Turkey

17-Mar-2016 - Dr Reddy’s Laboratories and TR-Pharma have partnered to manufacture biosimilar pharmaceuticals for the Turkish market.

CLARIFICATION

Good INNtentions? Naming debate hindering US biosimilar acceptance, expert

11-Mar-2016 - Is the debate surrounding unique international nonproprietary names (INNs) for biosimilar products a delaying tactic driven by reference biologic makers? One market analyst believes so.

I/O therapies boosting R&D funding & alliances, says Tufts

09-Mar-2016 - With more than 130 biotech and 20 pharmaceutical companies currently developing immuno-oncology (I/O) therapies, the global oncology market could reach $40bn by 2020, says Tufts.

Zarxio one year on: US biosimilars market still riddled with uncertainty, expert

09-Mar-2016 - It is still too early to tell how big an impact biosimilars will have in the US, according to an IP lawyer, a year after the FDA approved Sandoz’s Zarxio....

ANSM bans production at Theravectys' Paris facility until September

07-Mar-2016 - ANSM has banned Theravectys from manufacturing candidate vaccines and immunotherapies at its Paris facility until September after observing critical GMP deficiencies during an inspection last year.

Bigger discounts will boost biosimilar prescribing say US physicians

04-Mar-2016 - The larger the discount the more likely a US physician is to prescribe a biosimilar rather than an originator biologic according to the results of a survey.

JHL completes assembly of GE built off-the-shelf plant in Wuhan, China

29-Feb-2016 - JHL has completed “mechanical construction” of an off-the-shelf mAb plant in Wuhan, China days after UK regulators gave the go ahead for a trial of its rituximab biosimilar, JHL1101.

Heat Biologics stops enrolment in trial arm testing HS-410 as a bladder cancer monotherapy

25-Feb-2016 - Heat Biologics will no longer enrol patients in the arm of a Phase II trial examining its cell therapy HS-410 (vesigenurtacel-L) as a monotherapy for bladder cancer.

Biopharma CEO confidence levels wavering

19-Feb-2016 - While Bioparma CEOs remain confident in the industry as a whole, uncertainties still abound. 

Brought together by conjugation: CMC Biologics A/S and IDT Biologika form ADC pact

19-Feb-2016 - CMC Biologics A/S and IDT Biologika GmbH have teamed up to offer drugmakers an antibody drug conjugate manufacturing service.

EMA advocates more regular MRIs for MS patients on Biogen’s mAb Tysabri

17-Feb-2016 - Multiple sclerosis patients taking Tysabri (natalizumab) who are deemed to be at high risk for the lethal infection PML should have regular brain scans according to the EMA. 

Novartis nabs Remicade biosimilar candidate off Pfizer in Europe

17-Feb-2016 - Sandoz has picked up the European rights to PF-06438179, a biosimilar of Remicade (infliximab), after Pfizer was forced to divest the candidate.

FDA votes 21-3 in favour of Remicade biosimilar; Pfizer preps for 2016 launch

10-Feb-2016 - A US FDA advisory committee has voted overwhelmingly in favour of licensing Celltrion and Pfizer’s version of J&J’s Remicade, paving the way for the first US monoclonal antibody biosimilar....