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Pfizer has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics license application (BLA) for its proposed epoetin alfa biosimilar over manufacturing issues. The CRL relates to matters noted in a Warning Letter issued on February 14, 2017 following a routine FDA inspection of the company’s facility in McPherson, Kansas in 2016. This facility was listed as the potential manufacturing site in the BLA for the proposed epoetin alfa biosimilar. The issues noted in the Warning Letter do not relate specifically to the manufacture of epoetin alfa, noted Pfizer in a company statement. No additional clinical ...
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Eli Lilly and Company has completed a $90-million expansion of its Biotechnology Center in San Diego, California. The facility will accelerate the discovery of medicines within the company's core therapeutic areas of immunology, diabetes, oncology and neurodegeneration as well as the emerging area of pain, according to the company. The center features a new laboratory and an additional 180,000 square feet of working space, which is an increase of 145% compared to the former facility. Lilly hopes the facility will allow for closer partnership between the company and experts in biotechnology, discovery chemistry, and research technologies while also fostering ...
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Lubrizol Corporation has announced a $60-million investment in its LifeSciences business, focusing on new product solutions, capacity expansion, and additional cGMP manufacturing. According to Lubrizol, these investments will strengthen the excipients, polymers, drug formulation and manufacturing, and medical device contract manufacturing capabilities at its facilities. Additionally, commercial drug product manufacturing will be added at the company’s Particle Sciences facility in Bethlehem, Pennsylvania adjacent to the company's existing development and clinical trial manufacturing site. The space is expected to be operational in the fourth quarter of 2017 ...
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The US Food and Drug Administration (FDA) will hold a public meeting on July 18, 2017 to discuss ways to improve the generic-drug review process. The public meeting is part of an effort to create a broader understanding of the interplay between the existing legal and regulatory framework, available incentives and marketplace practices, and consumer access to generic drugs. In a blog posted on the FDA website, FDA Commissioner Scott Gottlieb outlined that the meeting is part of a larger process by the FDA in creating a Drug Competition Action Plan. "As part of this effort.., we’re announcing in the Federal Register our intent to hold a public meeting on ...
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Baxter International has signed an agreement with Dorizoe Lifesciences, a contract research and development organization, for development of more than 20 generic injectable products, including anti-infectives, oncolytics, and cardiovascular medicines. Dorizoe will work with Baxter to perform certain product development activities, and Baxter will hold worldwide manufacturing and commercialization rights. Financial terms of the agreement were not disclosed. Dorizoe provides services for pharmaceutical companies, including formulation development, analytical development, technology transfer and regulatory filing support. Baxter recently announced plans to ...
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Pfizer and Basilea Pharmaceutica, a Swiss biopharmaceutical company specializing in anti-infective and oncological medicines, have formed an agreement whereby Pfizer has been granted exclusive commercialization rights to Cresemba (isayuconazole), an antifungal drug, in Europe. Cresemba is indicated for treating adult patients with invasive aspergillosis and mucormycosis, which are two infections associated with high morbidity and mortality among immunocompromised patients, according to information from Pfizer. Pfizer will have exclusive rights to distribute and commercialize Cresemba in Europe, including Austria, France, Germany, Italy, and the United ...
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A roundup of the latest pipeline news, including from the pharmaceutical majors, featuring news from Novartis and Amgen as well as Seattle Genetics. Editor's Note: This article was updated on a continuous basis for news announced from Wednesday June 14, 2017 to Tuesday June 20, 2017. FDA Accepts Novartis’ NDA for Generic of GSK’s Respiratory Drug The US Food and Drug Administration (FDA) has accepted an abbreviated new drug application (ANDA) from Sandoz, the generics arm of Novartis, for a fluticasone propionate/salmeterol combination product, as a substitutable generic version of GlaxoSmithKline’s (GSK) Advair Diskus. Advair is GSK’s top-selling ...
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Johnson &Johnson's $30-billion buy of Actelion is the leading deal thus far in 2017, but what other deals have made the mark? The supplier side adds to important deals: Thermo Fisher's pending $7.2 billion acquisition of Patheon and AMRI's pending acquisition by private equity firms. So what other deals are making the mark thus far in 2017? The top 10 deals thus far in 2017 1. J&J’s $30-billion acquisition of Actelion.  By far, the largest deal thus far in 2017 is Johnson & Johnson’s (J&J) $30-billion acquisition of Actelion, a Swiss pharmaceutical company. The move provides J&J with a specialist in pulmonary arterial hypertension with a $1-billion ...
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Johnson & Johnson (J&J) has completed its $30-billion acquisition of the Swiss pharmaceutical company, Actelion. So what is the impact for J&J? The move provides J&J with a specialist in pulmonary arterial hypertension with a $1-billion plus franchise as J&J seeks to add assets to offset generic competition for its top-selling pharmaceutical, Remicade (infliximab). So what may be in store for J&J's pharmaceutical business? DCAT Value Chain Insights takes an inside look. Inside the deal J&J completed its previously announced acquisition of Actelion, a Swiss pharmaceutical company specializing in products for treating pulmonary arterial hypertension, ...
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Biogen has appointed Jean-Paul Kress, MD, as executive vice president and president, international, and head of Global Therapeutic Operations, effective June 19, 2017. Dr. Kress will have direct responsibility for worldwide commercial operations outside the US and will also oversee the Rare and Specialty Disease Asset teams. Dr. Kress will report directly to Chief Executive Officer Michel Vounatsos and be a member of Biogen’s Executive Committee. Prior to his appointment, Dr. Kress was most recently senior vice president, head of North America at Sanofi Genzyme, where he oversaw the multiple sclerosis, oncology, and immunology business units in the US ...
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TraceLink, a provider of track-and-trace technologies, will relocate its European headquarters to a larger, newly renovated office space in Uxbridge, UK. The move will accommodate an increase in its staff in the European Union (EU). In addition, the company has added two regional EU sales leaders: Manfred Voglmaier as vice president to lead the DACH (Germany, Austria and Switzerland) region and Renaud Delcroix as vice president to head up the southern Europe region. TraceLink expects to have nearly 400 employees by the end of 2017. Later this year, TraceLink will offer general availability to its EU-hosted Life Sciences Cloud to enable data residency in ...
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Parexel, a contract research organization, has formed a collaboration with Sanofi to advance the use of wearable devices for data collection in clinical trials. Wearables have the potential to address several challenges related to clinical trials and improve execution by increasing patients’ ability to participate, driving patient engagement, and creating more opportunities for decentralized trial sites, according to Parexel. The Parexel-Sanofi collaboration is designed to further explore the potential of patient sensors and wearable devices to remotely collect patient data during clinical trials. The two companies are jointly leveraging their clinical, ...
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Parexel, a contract research organization, has agreed to be acquired by Pamplona Capital Management, an investment firm, for $88.10 per share or approximately $5.0 billion, including Parexel net debt. The deal would take the now publicly traded Parexel private. The transaction is expected to close early in the fourth quarter of 2017, subject to the approval of a majority of Parexel shareholders and the satisfaction of other customary closing conditions. Parexel expects to hold a special meeting of shareholders to consider and vote on the proposed agreement with Pamplona as soon as practicable after the mailing of the proxy statement to shareholders. ...
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KBI Biopharma (KBI), a biopharmaceutical contract development and manufacturing organization, has agreed to acquire the assets of San Diego-based Alliance Protein Laboratories, an analytical services company specializing in biophysical characterization of biopharmaceuticals. Alliance characterizes therapeutic proteins, peptides, nucleic acids, and vaccines. The acquisition will expand KBI’s capabilities to include analytical ultracentrifugation. All of Alliance’s staff, including co-founders Tsutomu Arakawa, PhD, and John Philo, PhD, will join KBI through the acquisition with both continuing to oversee operations in the San Diego-based laboratory. KBI ...
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A roundup of the latest drug approval news, including from the pharmaceutical majors, featuring news from Novartis, Teva, Eli Lilly and Company as well as Adamis Pharmaceuticals. Editor's Note: This article was updated on a continuous basis for news announced from Wednesday June 14, 2017 to Tuesday June 20, 2017. European Commission Approves Novartis’ Biosimilar of Roche’s MabThera The European Commission (EC) has approved from Sandoz, the generics arm of Novartis, Rixathon, a biosimilar referencing Roche’s MabThera, a drug to treat cancer and autoimmune diseases, in all indications. MabThera/Rituxan is Roche’s top-selling drug with 2016 sales ...
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Merck KGaA’s corporate venture arm has created iOnctura, an immuno-oncology spin-out company based in Geneva, Switzerland. The corporate ventures fund of Merck KGaA will manage the investment and will be represented on iOnctura’s board of directors. iOnctura aims to develop a pipeline of selected assets that target and modulate mechanisms that drive immunosuppression in the tumor microenvironment, which has been a cause behind patients not responding to first-generation checkpoint inhibitors, according to information from Merck KGaA. The company is being formed around two assets from the healthcare R&D portfolio of Merck KGaA and three assets from the ...
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Takeda Pharmaceutical Company has completed the construction of a new EUR-100 million ($111-million) solid-dosage manufacturing facility at its site in Oranienburg, Germany. The facility is scheduled to begin operating at the end of 2017. The state of Brandenburg and the German federal government each contributed half of the approximately EUR 23 million ($25.6 million) in subsidies for the plant expansion. Takeda had announced in November 2014 that as a part of its initiative toward optimization of its global network, the manufacture of solid dosage form pharmaceutical products would be transferred from its plant in Osaka, Japan to the Oranienburg plant ...
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Hospira, a Pfizer company, is voluntarily recalling multiple lots of sodium bicarbonate for injection and other products due to sterility-assurance issues. The company is recalling 42 lots of 8.4% sodium bicarbonate -injection, USP, 50-mL vials, five lots of Neut (sodium bicarbonate 4% additive solution) 5-mL vials, five lots of Quelicin (succinylcholine chloride Injection, USP) 200-mg/10 mL vials, and seven lots of potassium phosphates Injection, USP, 45-mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products. ...
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Johnson & Johnson has completed its previously announced acquisition of Actelion, a Swiss pharmaceutical company specializing in products for treating pulmonary arterial hypertension, for a total purchase price of approximately $30 billion. The acquisition was completed through an all-cash public tender offer by Johnson & Johnson's Swiss subsidiary, Janssen Holding GmbH, to acquire all publicly held shares of Actelion Ltd for $280 per share, payable in US dollars. Actelion will now become part of the Janssen Pharmaceutical Companies of Johnson & Johnson. In connection with the completion of the public tender offer, Actelion has spun off its drug-discovery ...
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Bristol-Myers Squibb and SK Biotek Co., Ltd. have signed a definitive purchase agreement to sell Bristol-Myers Squibb’s small-molecule active pharmaceutical ingredient (API) manufacturing facility in Swords, Ireland, to SK Biotek, a wholly owned subsidiary of SK Holdings, based in Seoul, South Korea. The companies intend to complete the deal by the fourth quarter 2017, at which time SK Biotek will continue to manufacture the current portfolio of small-molecule pharmaceutical products at the site. The Swords facility currently manufactures APIs for a number of medicines, including Bristol-Myers Squibb’s and Pfizer’s Eliquis (apixaban), an anticoagulant. SK ...
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