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.
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.
Pierre Fabre has spared its biopharmaceutical research team from job cuts unveiled last night, signalling that high value biologics will be a focus for its reduced pharma R&D activities.
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.
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.
Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.
Italy has suspended the use of Fluad despite Novartis saying no causal relationship has been established between its seasonal flu vaccine and three deaths.
A Highly Specialised Technologies programme will evaluate increasingly niche and expensive biologics and gene therapies like Glybera, says NICE as it publishes guidance recommending the funding of Alexion’s Soliris.
The Tufts Center for the Study of Drug Development is out with a new study claiming that the average cost of bringing a new drug to market is around $2.6bn, though some are saying that number seems inflated.
WuXi PharmaTech has reported a 23% growth in manufacturing services and is planning to build a commercial biomanufacturing facility to meet the strong demand for biologics.
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.
Analytical and bioanalytical service provider SGS has made significant changes to its global network over the past few months to stay ahead of the competition curve.
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.
As single-use technology replaces traditional stainless steel technology in biomanufacturing, suppliers will own a larger portion of the supply chain, which is creating anxiety for end users such as Pfizer and Merck, experts say.
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.
MedImmune’s neurodegenerative disease partnership with the University of Cambridge is about working with “great scientists with great brains” according to a spokeswoman for parent company, AstraZeneca.
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.
Baxter International plans to set up a new global R&D center in Cambridge, Mass, for Baxalta, its biopharmaceuticals spinoff, which is expected be formally incorporated next year and headquartered in northern Illinois.
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.
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.
Reliance Life Sciences has been contracted to make the first Indian biosimilar of J&J’s Remicade (infliximab), though Epirus Biopharmaceuticals says it is looking to Fujifilm for its European supply.
As contract manufacturers continue to consolidate, some in the industry are questioning whether the resulting companies have the ability to offer the same services as the former individual companies.
At present Biosimilars save Europe roughly €2.40 per person, or €1.8bn a year, but by 2020 follow-on mAbs alone will shave €20bn off the continent’s healthcare bill according to researchers.
Charles River Labs (CRL) has singled out China as an area of “disproportionate growth” in biologics R&D and says it is on the hunt for preclinical acquisitions in the region.
A new list of biopharmaceuticals published by the US FDA provides limited information with only the entries for Neupogen, Perjecta and Granix including expiry dates.
Partnerships are a mixed bag.For every oppressed group yearning to throw off the yoke of their imperialist overlords, there is an Art Garfunkel or Daryl Hall solo album to illustrate the positive impact collaboration can have.
The monoclonal antibody drug Soliris has been recommended by NICE despite Alexion failing to justify the manufacturing costs contributing to the £3,150 ($5,140) price per vial.
