In a reversal from three years ago, the Court of Justice of the European Union (CJEU) ruled on Thursday that an organism incapable of developing into a human being is not a human embryo and may be patented.
Baxter has sold its pandemic flu portfolio and Vero cell technology to Nanotherapeutics in preparation for the launch of its haematology and oncology-based spinout company Baxalta.
Industry heavyweights and Singaporean development groups have unveiled a five-year roadmap to deal with the need for more employees in the fast-growing biologics manufacturing industry on the island.
In the ongoing fight over whether US pharmacists will be allowed to prescribe biosimilars in place of their reference products, the Generic Pharmaceutical Association has agreed on “compromise legislation” with innovator manufacturers.
AstraZeneca has continued the Big Pharma trend away from small molecule blockbusters and towards a biologics-heavy pipeline, announcing the closure of its Pulmicort facility in Massachusetts.
Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.
Stem cell therapies are on the brink of breaking through into the mainstream drug market, according to a GlobalData report, despite having been hindered by a lack of R&D funding.
Manufacturers developing Ebola vaccines will be immune from lawsuits following a decision by US HHS (Health and Human Services) to issue a declaration on the matter.
The first rival to AbbVie’s mega-blockbuster arthritis treatment Humira has hit the shelves in India, with Zydus Cadila claiming its launch began on Tuesday.
Biopharma heavyweights Amgen, Pfizer and a number of other companies offered their unique takes on the biosimilar draft guidance from the EMA, calling for more clarity and some new additions before the final draft takes effect.
Biologics are the next challenge for multinationals looking to enter the lucrative Chinese market, but such drugs must offer value and genuine innovation, say the CEOs of Merck KGaA and Chi-Med.
Ranbaxy Laboratories has launched the monoclonal antibody Infimab, the first Remicade (Infliximab) biosimilar, in India -- which is the first what could be a few home-grown biosimilar launches.
Third-party manufacturers anxious about Big Biopharma investments and downbeat industry reports can relax as experts concur “it’s a time of growth for biopharmaceutical outsourcing.”
There is an upsurge in biopharma demand for cell and gene therapy applications, says Transposagen as it inks a deal with Janssen to develop allogeneic Chimeric Antigen Receptor (CAR) T-cells.
An API facility in Singapore acquired by AbbVie on the site where it is building a $320m biologics plant will support the firm's antibody-drug conjugate (ADC) pipeline.
Novartis says it will keep biomanufacturing in-house and outsource more production of its small molecule portfolio in a strategy mirroring its Big Pharma peers.
Amgen has completed construction of its first $200m next-gen biomanufacturing facility in Singapore, which is outfitted with single-use technology to allow for greater flexibility.
With the goal of developing a thermostable tuberculosis vaccine, IDRI (Infectious Disease Research Institute) was awarded a contract from the NIH’s National Institute of Allergy and Infectious Diseases that could be worth up to $11.9m.
Drug companies are looking for ways to put biologics in topical creams or “zap” them into skin using electricity as more large molecules come off patent.
Bristol-Myers Squibb has announced plans to build a biologics facility in Ireland, eight months after winding down a small molecule API plant at the same site.
Like the US and EU, China’s SFDA is looking to ensure that approved biosimilars are proven to be similar to their reference drugs, according to an unofficial translation of the guideline by BioCentury.
The petition with the US FDA signals Amgen’s anger over Sandoz’s failure to disclose certain information from its biosimilar application, including how the biosimilar is manufactured.
GSK is keeping its Ebola vaccine production in-house, despite previously leaked documents which suggested the company could not ramp up volume of BS-2 manufacturing without impacting its other vaccine lines.
Reference drugs in biosimilar trials now only need to be “representative” of a product cleared in the EEA not approved themselves under guidelines issued by the EMA this week.
Despite plans to lay off more than 2,000 employees, Amgen is preparing for a biosimilar onslaught and expanding its portfolio to nine biosimilar programs.
Eli Lilly’ manufacturing network will give it the edge in the glargine insulin market, the firm says having received tentative approval of its “Lantus look-alike” from the USFDA.
A bioanalytical consultant has stressed the importance of drug developers testing commercial off-the-shelf (COTS) software following the discovery of potential issues with Thermo Scientific’s bioequivalence Kinetica platform.
Biopharmas struggle to comply with GMP requirements for personalised meds and the outstanding questions mean some are reluctant to invest according to German firm immatics.
Amgen is reviewing data from chronic kidney disease (CKD) patients to assess what impact switching to a 'biosimilar' version of its blood cell booster Aranesp (Darbepoetin Alfa) has had on their disease.
An Eli Lilly small molecule plant in Puerto Rico has been earmarked for closure as the company shifts its focus towards its insulin and biologics pipeline.
The WHO has accused biopharma firms of failing to invest in R&D to tackle Ebola due to the disease’s prevalence in poor African nations, as the death toll surpasses 4,000.
Biomanufacturing costs and the risk of extractables and leachables can be reduced by developing more compatible plastics, Sabic told Biopharma-Reporter.com at CPhI in Paris.
The EGA has called for more awareness surrounding the uptake of biosimilars in Europe after a report has shown upcoming products could cut healthcare provider spending by a quarter.
Nova’s vaccine stabilisation device, which enables vaccines to be dried and stabilized across a wide range of temperatures, has been awarded a US patent, though one researcher questions the utility of the device.
Chief among the potential drivers for the world’s biosimilar market is establishing a market in the US, which continues to stall, according to a new report.
As more than half a dozen companies are now vying to help treat and vaccinate Ebola victims in West Africa, where nearly 3,000 people have died from the illness, GlaxoSmithKline is taking the lead in getting product manufactured.
CRISPR, the gene-editing technology that could revolutionise biologics, is set to become a patent battleground as companies vie over who owns the tool and its products, says an intellectual property expert.
UK researchers have created “designer” amino acids which they say will allow them to build custom biologics from the ground up and avoid the pitfalls of recombinant expression.
Emergent BioSolutions has initiated a non-clinical study to demonstrate it can scale-up production of its anthrax vaccine, BioThrax, without making it less effective.
