Facilities

Lilly to sell California biomanufacturing plant

28-Apr-2015 By Zachary Brennan

Eli Lilly has hired CBRE Group to sell its biomanufacturing plant in Vacaville, California, which it claims is one of the largest bulk API manufacturing facilities for recombinant microbial-based biopharmaceuticals in the US.

Celgene in $450m deal to commercialise MedImmune's anti-PD-L1 candidate

28-Apr-2015 By Dan Stanton

AstraZeneca has inked a development and commercialisation deal with Celgene for its haematology programmed cell death ligand 1 (PD-L1) candidate, MEDI4736.

Bio-CMO sector to grow over 40% on Big Biopharma's burgeoning pipelines

24-Apr-2015 By Dan Stanton

Cheaper disposable manufacturing techs and increased demand for outsourced production will see more CMOs enter the contracting sector according to HighTech Business Decisions

Merck & Co. investing in Irish plant to support Keytruda supply

24-Apr-2015 By Dan Stanton

Merck & Co. will invest €11.5m ($12.5m) at a plant in Ireland to manufacture its oncology drug Keytruda, an anti-PD1 mAb recently approved by the US FDA.

StemBioSys closes $8m in funding to help launch its stem cell culture system

17-Apr-2015 By Zachary Brennan

San Antonio, Texas-based StemBioSys has closed an $8m round of Series A preferred stock financing that it will use to help launch its bone marrow-High Performance MicroEnvironment (BM-HPME) stem cell culture system.

Bayer spends $100m on haemophilia development in Berkeley

16-Apr-2015 By Fiona BARRY

Bayer has announced it will create a $100m (€94m) product testing site in California for its haemophilia A pipeline.

Rentschler expands biomanufacturing line with GE’s automated liquid chromatography system

15-Apr-2015 By Zachary Brennan

CDMO Rentschler Biotechnologie has added GE's 1000th ÄKTAprocess, which is an automated liquid chromatography system built for process scale-up and large-scale biopharma, at its site in Laupheim, Germany.

BMS inks gene therapy deal with uniQure worth up to $2bn

07-Apr-2015 By Dan Stanton

Bristol-Myers Squibb will use uniQure’s insect-cell based technology and manufacturing facilities to develop gene therapies for cardiovascular diseases in a deal potentially worth $2bn (€1.8bn).

US military strikes deal to secure adenovirus shots from Teva

03-Apr-2015 By Dan Stanton

Supply of the Adenovirus Type 4 and Type 7 Vaccine to all US military personnel has been secured through a five-year contract with Teva worth $170m (€156m).

GSK to begin Bexsero roll-out after striking deal with UK Government

01-Apr-2015 By Dan Stanton

GSK expects to begin supplying the UK with meningitis B vaccine Bexsero later this year after reaching an agreement on price.

Japan's yen for regenerative meds: Fujifilm to buy Cellular Dynamics

01-Apr-2015 By Gareth Macdonald

Fujifilm will buy Cellular Dynamics International (CDI) for $307m to add induced stem cells to its offering and further build in regenerative medicines.

Biotech fund Flagship Ventures raises $537m for biggest round yet

27-Mar-2015 By Fiona BARRY

The venture capital fund that launched Acceleron, Moderna, and Bind Therapeutics has raised $537m (€493m) for another round of funding.

US FDA rejects Amgen bid to force biosims firms to share info before review

27-Mar-2015 By Gareth Macdonald

Biosimilar firms seeking US approval will not have to commit to share manufacturing data with reference drug firms before reviews, after the FDA rejected Amgen’s request for such a rule.

Genentech plans $125m expansion of Oregon manufacturing facility

27-Mar-2015 By Zachary Brennan

Genentech will invest more than $125m to expand its fill/finish facility in Hillsboro, Oregon.

AstraZeneca teams with Harvard to make human beta cells for drug screening

25-Mar-2015 By Gareth Macdonald

Sourcing human beta cells may soon no longer be a challenge for AstraZeneca diabetes researchers thanks to a new partnership with stem cell scientists at Harvard University.

update

Novasep joins Lonza as Mydicar API producer in deal with Celladon

25-Mar-2015 By Gareth Macdonald

Novasep and Lonza will both make the API for Celladon's heart attack therapy, Mydicar.

AbbVie bucks Puerto Rico departure trend with $30m expansion

25-Mar-2015 By Fiona BARRY

AbbVie is investing $30m (€27m) in contract manufacturing facilities in Puerto Rico and plans to create 100 jobs over the next two years.

Good news for Sandoz? GSK confident UK will accept Bexsero price proposal

24-Mar-2015 By Gareth Macdonald

Speculation GSK's meningitis B vaccine Bexsero will soon be available on the UK National Health Serivice will be welcomed by campaigners, protein supplier Sandoz and its parent company, Novartis.

Judge rejects Amgen’s attempt to block first US biosimilar launch

20-Mar-2015 By Zachary Brennan

A district court judge from California has denied an injunction by Amgen meant to stop the launch of the first biosimilar approved by the US FDA – Sandoz’s Zarxio (filgrastim-sndz).

Biobetters may fare better than biosimilars in some therapeutic areas, says analyst

11-Mar-2015 By Gareth Macdonald

Biobetters stand a better chance of winning market share than lower cost biosimilars in some indications according to new analysis.

Orgenesis buys cell therapy CMO to cut manufacturing costs and diversify revenue stream

11-Mar-2015 By Gareth Macdonald

Orgenesis has bought Masthercell SA to take control of production of its Type 1 diabetes cell therapy candidate ahead of clinical trials.

US FDA expects more resources to fund biosimilar reviews and plant inspections

10-Mar-2015 By Gareth Macdonald

Biosimilars will mean more facility inspections and reviews according to the US FDA, which is confident its funding will be increased accordingly.

Update

FDA approves first US biosimilar from Sandoz

06-Mar-2015 By Zachary Brennan

The FDA on Friday morning approved Sandoz’s Zarxio (filgrastim-sndz), the first biosimilar product approved in the US.

CureVac to build plant with Gates Foundation money

06-Mar-2015 By Gareth Macdonald

CureVac will build a manufacturing facility for mRNA vaccines after a $52m (€46m) Gates Foundation investment that also brings an IPO one step closer according to majority shareholder Dietmar Hopp.

Kite broadens CAR-T manufacturing, research agreement with NCI

06-Mar-2015 By Zachary Brennan

Clinical-stage biotech Kite Pharma has broadened its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI).

Valeant sacks Dendreon admin staff and plans manufacturing savings

04-Mar-2015 By Gareth Macdonald

Valeant has started cutting jobs at Provenge manufacturer Dendreon just over a week after it acquired the bankrupt firm for $495m (€444m).

Hemispherx upgrades New Jersey Alferon plant months after drug shows anti-Ebola efficacy

03-Mar-2015 By Gareth Macdonald

Hemispherx has installed a 600 litre bioreactor at its manufacturing facility in New Jersey and plans to seek approval to restart production of its alpha interferon product, Alferon N Injection.

Regulations not the only barrier to biosimilars in the US say analysts

03-Mar-2015 By Gareth Macdonald

A robust US biosimilars market is still some way off according to analysts who say interchangability, doctors’ safety concerns and patient demands should be considered alongside the regulatory environment by firms mulling entry.

US FDA postpones Celltrion's Remicade biosimilar review meeting

27-Feb-2015 By Gareth Macdonald

The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information.

Japanese companies acquire CMO KBI Biopharma

26-Feb-2015 By Zachary Brennan

Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and...

Apotex's Neupogen biosimilar could be battling Sandoz's copycat in the US in 2015

26-Feb-2015 By Gareth Macdonald

Apotex’s Neupogen (filgrastim) copycat Grastofil could be on US pharmacy shelves as early as December, after the US Food and Drug Administration (FDA) started its review this week.

Cynata validates stem cell manufacturing process at Wisconsin biomanufacturing site

24-Feb-2015 By Zachary Brennan

Australian stem cell and regenerative medicine company Cynata Therapeutics is now set to scale up manufacturing of its mesenchymal stem cells (MSCs) for therapeutic use.

Celltrion: Remsima could save UK, Italy and France $336m in five years

20-Feb-2015 By Gareth Macdonald

Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.

IDRI receives $4m from BARDA to create adjuvant manufacturing hub

20-Feb-2015 By Zachary Brennan

Seattle-based Infectious Disease Research Institute (IDRI) has received $4m in funding from the US Biomedical Advanced Research and Development Authority (BARDA) to develop an adjuvant manufacturing hub with both preclinical and clinical expertise to...

Novasep signs €4.7m biomanufacturing deal with biotech

18-Feb-2015 By Zachary Brennan

Novasep has signed a €4.7m ($5.4m) agreement with Celladon, a clinical-stage biotechnology company, to prepare to supply the drug substance for the heart failure treatment Mydicar.

Repligen finishes plant expansion and forecasts higher tech revenues in 2015

13-Feb-2015 By Gareth Macdonald

Repligen has finished an expansion at its US filtration system facility eight months after bolstering its offering in this area by buying a platform from Refine Technology.

GSK invests further in vaccines with $190m buy of GlycoVaxyn

13-Feb-2015 By Zachary Brennan

Fresh of its acquisition of Novartis’ vaccine business, GlaxoSmithKline is doubling down with the purchase of GlycoVaxyn AG, a Swiss-based specialist vaccine maker, for $190m (£124m).

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'Invest, don't protest' ex-Teva CEO warns biosimilar detractors

11-Feb-2015 By Dan Stanton

Big biotech firms risk the empty pipeline pitfalls of old pharma if they protect their drugs from biosimilars rather than invest in innovation, ex-Teva CEO Jeremy Levin warns.

One in the eye for Lucentis? Pfenex says Pfizer takeover will benefit Hospira pact

11-Feb-2015 By Gareth Macdonald

Pfenex expects its new Lucentis biosimilar partnership to benefit from Pfizer’s economic clout after the Hospira takeover completes.

Juno Therapeutics adds new biomanufacturing facility in Washington, will continue using CMOs

10-Feb-2015 By Zachary Brennan

Cell-based cancer immunotherapy company Juno Therapeutics has entered into a lease agreement for a manufacturing facility in Bothell, Washington to produce its developing cell therapies.

GSK to consolidate vaccines R&D ahead of Novartis unit takeover

09-Feb-2015 By Gareth Macdonald

GSK will close a vaccine R&D lab in Montana and establish a centralised development hub as it prepares to takeover Novartis jabs unit.

Sanofi to hike biologics CapEx in 2015

06-Feb-2015 By Gareth Macdonald

Sanofi will invest in biologics and vaccine manufacturing capacity in 2015 to sustain product launches and ease constraints that impacted its Sanofi Pasteur division in the past few years.

Teva looks to plug gap in its biomanufacturing network

06-Feb-2015 By Dan Stanton

Teva has begun addressing the gap in its biologics production capability and says a significant manufacturing facility is on its way.

Provenge in a dish not yet sold: Valeant ups Dendreon offer after competing bids

06-Feb-2015 By Gareth Macdonald

Bankrupt cell therapy firm Dendreon has attracted more suitors according to stalking horse bidder Valeant, which upped its offer for the Provenge (sipuleucel-T) developer to $400m this week.

Merck & Co. predicts forced Remicade price cuts in European markets in 2015

04-Feb-2015 By Gareth Macdonald

Remicade will be cheaper in Europe according to Merck & Co., which predicted Government mandated price cuts in some markets.

Long manufacturing timeline hampers annual flu vaccine strain selection, experts say

04-Feb-2015 By Zachary Brennan

US government scientists told a House subcommittee on oversight and investigations on Tuesday that the six months production time necessary for flu vaccine manufacturers can create difficulties for health experts selecting the appropriate virus strains...

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