Korean authorities continue to place pressure on the CDMO, after prosecutors raided the office of the national stock exchange regarding behaviour preceding the public listing of Samsung BioLogics.
The US FDA issues Biocon a Form 483 with two observations, including failure to establish proper aseptic practices and lack of follow-up on data discrepancies.
Regenerative medicine raised $13.3bn in funds during 2018 but investors question whether treatments can be manufactured consistently, according to AMR annual report.
As technology has advanced, rare diseases have been met with therapies that target the cause of the condition, enabling the global market for orphan drugs to reach an expected $262bn by 2024.
Biogen agrees Nightstar acquisition for $800m to take on its pipeline of AAV treatments for retinal disorders, diversifyingy its pipeline in the rare disease market.
Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
The global cell line development market grows steadily with a predicted revenue of $7.5bn by 2024, each component of the market to see CAGR between 10-15%.
A judge has ruled in favour of AbbVie, finding that Boehringer should disclose its US launch plans for its Humira biosimilar if it wants to prove patent protection inhibited its commercial release.
GE announced a change of plans regarding its GE Healthcare business, choosing to sell off the BioPharma business for $21.4bn rather than initiate an IPO.
Celltrion Healthcare’s head of medical and marketing outlines how the US biosimilar market is evolving and how manufacturing efficiency could become a key distinguisher from competitors.
The WHO establishes a multi-disciplinary committee to advise on the ethical and scientific challenges of human genome editing, as the technology’s capability and utilization grows in the industry.
Pfizer’s Zirabev receives approval from the European Commission as a biosimilar to Roche’s Avastin, which brought in sales of CHF1.8bn in Europe during 2018.
Health Canada opts not to include the additional suffix after biologics’ non-proprietary name, instead relying on the brand name and products’ identification number.
In full-year financials, AstraZeneca announced that its R&D arm, MedImmune, will be absorbed into the overall company as it restructures its R&D units into specific therapy areas.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
While last month saw many pharma executives leaving their positions to head towards smaller biotech companies, this month saw members of the industry climbing the ladder from various different starting points.
Following the US FDA issuing a CRL to Immunomedics, the agency has revealed its inspection found instances of data integrity breaches and manipulation.
The US market for insulin biosimilars is set to open up in 2020, and the head of biopharmaceuticals at Sandoz explained why he is confident of an ‘acceleration’ of the US biosimilar market in the coming years.
NICE recommends CAR T-cell treatment Kymirah to be covered by the Cancer Drugs Fund to treat adult patients with lymphoma, despite previous negative appraisals.
Active competition law enforcement is encouraging the pharmaceutical industry to provide more affordable medicines and promotes innovation, suggests EC report.
Celgene and Kyn Therapeutics enter a licensing agreement to develop Kyn’s immuno-oncology pipeline for investigative therapies after Celgene was acquired by BMS.
European generics industry faces opposition while pushing for the SPC manufacturing waiver to be altered so it allows for the production of drugs under patent for non-EU countries.
The US FDA is faced with lapsed funding appropriations as the US government shutdown continues, causing the agency to focus on addressing immediate threats to consumer safety.
Biosimilar approvals in the US have increased by 600% and with biologic patent expiration dates approaching, biosimilar applications are on the rise as well.
Eli Lilly and Innovent announced that their jointly developed anti-PD-1 drug gained approval in China, becoming the second domestically produced treatment of this type.
With nearly 300 cell and gene therapies in development, targeting more than 100 diseases, 2019 could be set to be a big year for cell and gene therapies.
