China’s authorities’ condemnation of Changsheng Biotechnology, after it was found to have falsified data regarding a rabies virus, has caused public concern over the domestic vaccine market.
Major pharmaceutical firms Novartis, Roche, and Pfizer have reacted to the US FDA’s Biosimilar Action Plan, which aims to “strike a balance” between innovation and market competition.
The US FDA has released draft guidance documents on gene therapy programmes, which “should help sponsors avoid expending time and resources on unproductive drug development efforts,” says expert.
AbbVie’s mega-blockbuster Humira is facing biosimilar competition, but another patent licensing agreement, this time with Mylan, sees the company securing exclusivity through to 2023 in the US.
South Korea’s SFC has alleged that Samsung BioLogics had intentionally omitted information regarding the joint venture agreement with Biogen that created Samsung Bioepis.
BioIndustry Association, a trade organisation for bioindustry, has voiced its frustration at the lack of clarity facing those in the industry over Brexit.
President Trump’s immigration travel ban will deny pharmaceutical companies the opportunity to hire the ‘best and brightest,’ says Massachusetts Biotechnology Council CEO.
Cel-Sci has won the breach of contract ruling against its former CRO inVentiv, after it “slowed down clinical development of Cel-Sci’s Phase III cancer immunotherapy,” says CEO.
The Republic of Ireland’s competitive corporate tax rate represents a ‘stability’ that may not be found in other economies, says IDA Ireland executive.
The US FDA has approved Merck & Co.’s bestseller Keytruda for two additional oncology indications – cervical cancer, and relapsed primary mediastinal large B-cell lymphoma.
Cellectis’ third gene-edited, ‘off-the-shelf’ CAR T-cell candidate is set to enter clinical development after the US FDA approved an IND application for UCART22.
The US FDA has issued a complete response letter to Amgen for its biosimilar version of Roche’s Herceptin, marking the agency’s third trastuzumab candidate rejection this year.
The European Commission has angered the biopharma industry by proposing to relax the rules detailing when companies can manufacture biosimilars and generics in the region.
TapImmune would consider a partnership deal with a major pharmaceutical firm in a non-Caucasian country, such as Japan or China, if “very compelling” from a financial standpoint, says CEO.
The US Department of Justice has filed a lawsuit to stop US Stem Cell Clinic from performing autologous stem cell procedures at the request of the US Food and Drug Administration (FDA).
Merck & Co. and Roche have ceased enrolment in separate clinical studies trialling Keytruda and Tecentriq as single therapies, due to a lower rate of survival in patients.
The FDA has approved Pfizer’s Retacrit, a biosimilar alternative to Amgen’s Epogen and J&J’s Procrit, which the company will price at a "significant discount."
Agilent's 15,000-square-foot expansion will increase its capacity to meet a growing demand for next-generation sequencing products from its genomics group.
Roche’s immunotherapy combination has received priority review after Phase III trial results showed potential to provide significant survival benefit in the initial treatment of NSCLC.
Novartis has scored a second US FDA approval for CAR T-cell therapy Kymriah, indicated to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma.
Johnson & Johnson has reported plans to cut costs across its supply chain as it looks to shifts focus from “older parts” of its portfolio to newer technologies and capabilities, such as in biologics, says CFO.
There is a lack of third-party capabilities in the autologous cell therapy space says the new editor of PharmSource ahead of this year’s Interphex Convention.