WuXi PharmaTech has predicted that demand for its biopharmaceutical manufacturing services will increase this year just days after upping its guidance for fiscal 2013.
The US regulatory scientists who oversee biopharmaceuticals appear to be getting the funding they asked for after politicians pass a $1.2tr (€882bn) Government spending plan for fiscal 2014.
Johnson & Johnson (J&J) has called on the US FDA to prevent biosimilars being given the same non-proprietary names as their original biologics, while the European Generics Association maintains the practice is “proven to be safe” and “supported...
Brad Pitt made himself sick to avoid a zombie virus in World War Z but, despite some real world precedents, he was lucky his gamble paid off according to virus experts we asked.
Good news for stem cell scientists this week with new data indicating that patients support the use of induced pluripotent stem cells (iPSC) in biopharmaceutical research if proper consent is obtained.
The climate for biomanufacturing has changed according to Pfizer, which has set out to win more contracting work for its hormone plant in Sweden and says it will even consider making large molecule drugs for Big Pharma rivals.
Choosing the same biomanufacturing tech supplier for development and commercial systems cuts scale steps and reduces lead times according to Cobra Biologics.
Researchers recently genetically engineered rice to produce high yields of an antibody that proved effective in a study to treat and prevent rotavirus-induced gastrointestinal symptoms in mice.
The European Commission (EC) has cleared Thermo Fisher’s acquisition of Life Technologies subject to certain divestitures including its media and sera for cell culture business.
Kadcyla has become the second antibody-drug conjugate (ADC) to be available in Europe, triggering a $5m milestone payment by Roche to technology partner Immunogen.
Parexel has seen small and mid-sized biopharma demand for development services decline in recent months according to an anaylst who attended the CROs presentation at the Jefferies Global Healthcare conference this week.
Biosimilar clinical trials are increasing but levels of physician oversight and regulatory decisions are still hurdles to overcome, say Parexel, PPD and Vince & Associates.
Unclear terms in US biosimilars laws and the high cost of filing with the Food and Drug Administration (FDA) has set the stage for legal battles according to a lawyer who spoke at AAPS this week.
With more and more biopharmaceutical firms developing therapeutic antibodies public knowledge of these powerful molecules is increasing, which is good news given how badly they've been portrayed in films so far.
Novartis has joined the debate regarding the international nonproprietary names (INNs) of biologics saying some companies are casting unnecessary doubt on biosimilars under a guise of pharmacovigilance.
DSM says its new biomanufacturing facility will benefit the Australian biotech sector, overcoming the problems of distance with foreign contract manufacturers.
Stada Arzneimittel has licensed European rights to a biosimilar version of the white blood cell booster filgrastim from Apotex and says it is not worried by competitors already in the market.
Gilead will spend $47m (Eur 34m) to expand a Canadian plant at which it produces biopharmaceuticals for trials, including its Ph III hep C drug candidate sofosbuvir.
Biopharmas should stop green lighting safe, mediocre candidates and focus on developing drugs that are genuine scientific breakthroughs to control spiralling R&D costs, according to industry guru Bernard Munos.
GlaxSmithKline will wait to ramp up manufacturing capacity of its promising malaria vaccine until after it makes its way through the regulatory process.
The Governor of California has vetoed a bill set to constrict the dispensing of biosimilars due to its premature nature, much to the disappointment of Amgen and Genentech.
With in-house production and manufacturing capacity, as well as a deal with Merck Serono, India-based generics giant Dr. Reddy’s is looking to bring as many as four biosimilars to the EU market by 2019.
“Reports of my death have been greatly exaggerated” said American author Mark Twain, and yesterday Janet Woodcock - another American author, albeit of a number of US drug initiatives - echoed his words denying rumours of her imminent retirement.
India’s biomanufacturing sector has immense potential, but policy, infrastructure and finance-related issues are holding it back, say both Biocon and analysts.
Investing in antibody-drug conjugates (ADCs) made sense despite CMO competition and the fact few of these hybrid drugs have been approved to date says Carbogen Amcis CEO, Mark Griffiths.
Kemwell says it intends to open the Indian market to contract biomanufacturing as it signs its first monoclonal antibody (mAb) development and manufacture agreement for a European biopharma.
Agilent Technologies has officially separated its biopharma service offerings from its electric measurement group to create two separate companies, the life science portion of which is expected to bring in about $3.9B in FY2013.
A new platform to help biopharma companies discover antibodies is also helping them go after more difficult targets and earn more collaborations with top biopharma companies.
The updated draft guidance calls for fully validated bioanalytical methods for any pivotal studies used to obtain approval or labelling, though less validation may be sufficient for a sponsor’s internal decision making.
Cytotoxics will be a key growth opportunity for third-party manufacturers as biopharma increases its injectables outsourcing over the next few years, an industry report has predicted.
Roche has agreed to research, develop and commercialize Inovio Pharmaceuticals' vaccine delivery tech as well as its multi-antigen DNA immunotherapies targeting prostate cancer and hepatitis B.
The team behind a new Malaysian biotechnology hub – the Bio-XCell Biotechnology Park - has launched a new package designed to attract biomanufacturers.
US acceptance of biosimilars is “not a question of if, only of when,” according to Hospira which received a European Commission (EC) OK of its Remicade copycat yesterday.
The $165bn biopharma market is expected to grow by about 15% annually, driven largely by increasing revenue growth from recombinant monoclonal antibodies (mAbs), according to a recent report.
Baxter and Coherus Biosciences have become the latest firms to try and develop a biosimilar version of the RA treatment Enbrel in a new collaboration announced this week.
