Global Markets

UK must avoid no-deal Brexit, says British pharma group

Crashing out of the European Union without a deal will be catastrophic, says the head of the Association of British Pharmaceutical Industry (ABPI) Mike Thompson.  However, the pharmaceutical industry is stockpiling medicines in preparation, he confirmed. As the UK braces itself for an unprecedented and potentially calamitous exit from the European Union (EU) on March 29th, firms including Pfizer, Merck & Co, and Sanofi, as well as UK-headquartered GlaxoSmithKline and AstraZeneca, have reportedly been stockpiling medicines. This was confirmed today by…

BMS $74bn Celgene deal to create ‘number one oncology franchise’

The acquisition of Celgene will boost Bristol-Myers Squibb’s commercial portfolio and clinical pipeline and create synergies of $2.5 billion, the firm says. The new year has started with an M&A bang, with pharma giant Bristol-Myers Squibb (BMS) announcing its intentions to acquire its immune-oncology partner Celgene in a deal valued at $74 billion (€65 billion). According to Giovanni Caforio, CEO of Bristol-Myers Squibb, four value areas drove the merger. The first is creating leading franchises in oncology, immunology and inflammation…

Avid: Balancing MAb capacity with industry’s growing needs

Monoclonal antibody (MAb) capacity remains roughly in balance with industry’s needs but firms should look to procure manufacturing services early to guarantee their projects, says CDMO Avid Bioservices. Twelve months ago, Peregrine Pharmaceuticals sold its internal monoclonal antibody (MAb) programs and became a pure contract development and manufacturing organization (CDMO) under the Avid Bioservices title. The CDMO has GMP facilities in Orange County, California offering biopharma firms both stainless steel and single-use biologics manufacturing services. As such, the firm spoke to…

Biotech patents: How to protect from IP threats

Thomas Wolski, partner at The Webb Law Firm, says biotech firms must file more patent applications earlier to overcome the threats of US legal uncertainty and unclear guidance. Uncertainty in US laws is one of the threats that the biotech industry has and continues to face when it comes to patents. And it seems like every patent case that the Supreme Court takes these days has a strong chance of reversing the Federal Circuit’s decision. To compound the problem, Congress’s…

Business must harness tech and innovation to thrive, says new Locate Bio CEO

Biotech must work at the frontiers of biology and innovation while operating in a highly regulated environment says business development expert Nick Staples, the new CEO of Locate Bio. UK-based cell and gene therapy firm Locate Bio has had a reshuffle at the top, hiring veteran biopharma business executive and industry analyst Dr Nick Staples as CEO. BioProcess Insider spoke with Staples to find out his vision for Locate Bio, and how best to manage the often conflicting business and…

Novartis teams with Chinese drugmaker to enter insulin biosimilars space

Novartis division Sandoz has partnered with Chinese manufacturer Gan & Lee to bring biosimilar insulins to the US and EU. The agreement will see China’s Gan & Lee supply Sandoz with insulin glargine, lispro and aspart products for use in patients with type 1 and type 2 diabetes for commercialization in Europe and the US, along with other key markets. “After conducting a significant review, Sandoz decided to collaborate with Gan & Lee, the third largest insulin distributor headquartered in…

Global biologics demand driving MabPlex expansions

MabPlex has opened a facility in Yantai, China with up to 24,000 L of single-use capacity to serve the growth in biomanufacturing demand. MabPlex International, a contract development and manufacturing organization (CDMO) focused on monoclonal antibodies and antibody-drug conjugates (ADCs), has expanded its global offering through the opening of a commercial plant in Yantai, China. The ribbon cutting ceremony took place in September and according to the firm, the expansion helps feed the global demand in biologics services. “The demand…

Teva two: FDA approves Celltrion-made Herceptin biosimilar

The US FDA has approved a second biosimilar of Roche’s breast cancer drug Herceptin (trastuzumab): Celltrion’s Herzuma, to be marketed by Teva. In 2016, Israeli firm Teva Pharmaceutical Industries expanded its biosimilar portfolio by teaming up with Korean drugmaker Celltrion. The $160 million (€141 million) deal gave Teva the US rights to versions of Roche’s Rituxan (rituximab) and Herceptin. The former received US Food and Drug Administration (FDA) approval last month, and now the latter has been given the regulatory…

Korea exchange: Celltrion probed as Samsung Bio resumes trading

An investigating has begun into alleged accounting irregularities between Celltrion Inc. and its affiliate Celltrion Healthcare. Meanwhile, Samsung BioLogics has recommenced share trading a month after being hit by its own accountancy problems. South Korea’s Financial Supervisory Services (FSS) is looking into the business dealings of drugmaker Celltrion Inc and its wholesaler and marketing affiliate Celltrion Healthcare, according to Korean news outlet YTN. The article claimed Celltrion Healthcare violated accounting rules by selling the domestic distribution rights of biological medicines…

Manufacturing shutdowns and idle capacity mar Avid’s Q2

Business is up and proposal requests are increasing, but planned sequential maintenance shutdowns of both Avid’s manufacturing facilities hit the CDMO’s second quarter revenues. For the second quarter FY19, Avid Bioservices reported manufacturing revenue of $10.2 million (€9 million), down 20% on the same period last year. The firm – which became a pureplay contract development and manufacturing organization (CDMO) in January 2018 – attributed the drop to planned sequential maintenance shutdowns of both its Californian production plants. The Franklin…