News & Insights

Be the first person to recommend this.
Lumis Global Pharmaceuticals, a Wuhan, China-based manufacturer of active pharmaceutical ingredients (APIs), has received a Warning Letter from the US Food and Drug Administration (FDA) for cGMP violations at the companys drug manufacturing facility in Wuhan. The FDA noted the violations during an inspection of the plant in September 26-28, 2016, which also included a misbranding of the the active pharmaceutical ingredient (API), gabapentin. The FDA reviewed Lumis November 9, 2016, response and noted that it addressed some of the agencys observations, but did not address other issues that had been noted. During its inspection, the FDA observed the following: ...
0 comments
Be the first person to recommend this.
Badrivishal Chemicals & Pharmaceuticals, a Talegaon Dabhade, India-headquartered manufacturer of active pharmaceutical ingredients (APIs) and specialty chemicals, has received a Warning Letter from the US Food and Drug Administration (FDA) for cGMP violations at the companys Taluka Maval, India drug manufacturing facility. The violations were noted during an FDA inspection of the facility in August 16-19, 2016, and the agency reviewed Badrivishals September 8, 2016 response. During its inspection, the FDA made several observations, namely that Badrivishals water purification system was not adequately monitored and controlled, which poses a risk to the safety ...
0 comments
Be the first person to recommend this.
The US Food and Drug Administration has recently issued Warning Letters to two India-based and one China-based active pharmaceutical ingredient (API) manufacturers for cGMP violations at their respective manufacturing facilities. These include drug manufacturing facilities in India run by Megafine Pharma and Badrivishal Chemicals & Pharmaceuticals, based in Mumbai and Talegaon Dabhade, India, respectively, and a drug manufacturing facility in China run by Lumis Global Pharmaceuticals, headquartered in Wuhan, China. The FDAs observations during a September 19-23, 2016 inspection of Megafines Gujara, India drug manufacturing facility included a failure to ...
0 comments
Be the first person to recommend this.
Sun Pharmaceutical Industries, a Mumbai, India-headquartered specialty generic pharmaceutical company, has been informed by the US Food and Drug Administration (FDA) that the agency will lift an import alert imposed on the companys manufacturing facility in Mohali, Punjab, India and remove the facility from Official Action Initiated (OAI) status. The proposed action will clear Sun Pharma to supply approved products from the Mohali facility to the US market, subject to normal FDA regulatory requirements. An OAI status is conferred on a facility when the FDA finds objectionable conditions, and regulatory and/or administrative sanctions by the FDA are indicated. ...
0 comments
Be the first person to recommend this.
Mayne Pharma, a Salisbury South, Australia-headquartered contract development and manufacturing organization and drug delivery technology company, has acquired the rights to the fentanyl transdermal delivery system (TDS), 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, and 100 mcg/hr from Par Pharmaceutical, the Chestnut Ridge, New York-based subsidiary of Endo International. Fentanyl TDS is an AB-rated generic equivalent to Janssen Pharmaceuticals Duragesic (fentanyl), indicated for managing pain in opioid-tolerant patients severe enough to require daily treatment. Fentanyl TDS was developed by Corium, a commercial-stage biopharmaceutical company headquartered in Menlo ...
0 comments
Be the first person to recommend this.
Friulchem S.p.A., a Vivaro, Italy-based contract development and manufacturing organization for innovator and generic pharmaceutical products for human and veterinary use, reports on several recent patent developments. The company has received a patent in the US with patent review underway in Europe and Mexico relating to new methods for preparing highly purified rifaximin, a semi-synthetic antibiotic, and for a new pseudo-crystalline form of rifaximin. The process is based on the synthesis of rifaximin from rifamycin O, an antibiotic, and involves crystallization and further purification of rifaximin, which is then used in finished drug products for human ...
0 comments
Be the first person to recommend this.
Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) have been expanding operations to support the development and manufacturing of parenteral drugs. So what are some key projects? CDMOs/CMOs have been expanding organically and through acquisitions. DCAT Value Chain Insights takes a look at recent activity. A roundup of recent activity Several CDMOs and CMOs have announced investments, completed expansions, and/or made acquisitions to expand their capacity and production capabilities for the development and manufacturing of parenteral drugs. A roundup of key activity in 2016 and in 2017 ...
0 comments
Be the first person to recommend this.
3P Biopharmaceuticals (3P), a Noin, Spain-headquartered contract development and manufacturing organization for biologics, has signed a collaboration agreement with Ondek, a Sydney, Australia-based biopharmaceutical company developing natural immune modulatory products, for the production of an immunotherapy drug candidate based on the Helicobacter pylori organism. The agreement will allow Ondek to transfer its proprietary technology to the production site of 3P Biopharmaceuticals, where 3P will perform the scale up and non-GMP manufacture of the drug candidate under anaerobic conditions of the H. pylori product that will be used for preclinical studies. ...
0 comments
Be the first person to recommend this.
The Food and Drug Administration (FDA) is considering establishing a new Office of Patient Affairs to enhance future patient engagement by providing a more transparent and accessible experience for patient communities. FDA recognizes the importance of engaging with patients, caregivers, and their advocates in the medical product development process under the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law in July 2012. The FDASIA expanded the FDA's authorities and strengthened its ability to safeguard and advance public health in several areas, including increasing stakeholder involvement in FDA regulatory processes. ...
0 comments
Be the first person to recommend this.
Pfizer has issued a voluntary Class III recall for 582,165 vials of the gastrointestinal drug, Protonix (pantoprazole sodium) for injection, equivalent to 40 mg pantoprazole per vial, due to subpotency concerns following out-of-specification results on drug potency at the six-month stability time point. The recall was initiated in November 2016 and noted down by the US Food and Drug Administration on March 10, 2017. A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. The recall applies to eight lots of product made in France and distributed in Philadelphia by Wyeth Pharmaceuticals, ...
0 comments
Be the first person to recommend this.
Allergan's wholly-owned subsidiary, Allergan Pharmaceuticals International Limited, has entered into a strategic research and development alliance with Editas Medicine, a Cambridge, Massachusetts-based genome editing company, under which Allergan will receive exclusive access and the option to license up to five of Editas Medicine's genome-editing ocular programs in a deal worth $90 million. The agreement includes Editas Medicines lead drug program for Leber congenital amaurosis, a rare genetic eye disorder affecting the retina, which is currently in pre-clinical development. The agreement covers early-stage ocular programs targeting diseases based on Editas ...
0 comments
Be the first person to recommend this.
Takeda Pharmaceutical has partnered with Innovation Network Corporation of Japan (INCJ), a Tokyo-headquartered public-private partnership focused on promoting innovation and enhancing business value in Japan, and Medipal Holdings, a Tokyo-headquartered networking group of manufacturers, medical institutions, and retailers, to jointly invest a total of Japanese yen 10 billion ($87 million) to establish a new biotechnology venture company that will be named Scohia Pharma. Following its launch within Takedas Shonan Research Center, Scohia Pharma will sign a license agreement with Takeda for eight of Takedas renal, metabolic, and cardiovascular research and development ...
0 comments
Be the first person to recommend this.
Daiichi Sankyo has entered into a drug discovery and licensing agreement with Heptares Therapeutics Limited, a Hertfordshire, UK-headquartered clinical-stage biopharmaceutical company and a wholly owned subsidiary of Sosei Group Corporation, a Japanese biopharmaceutical company, for a G protein-coupled receptor (GPCR) that plays a role in relieving pain. Under the agreement, Heptares will apply its proprietary stabilized receptor (StaR) technology to engineer thermally stabilized forms of the GPCR as the basis for the drug discovery program. Heptares will also employ advanced structural biology and rational drug design approaches, X-ray crystallography, and ...
0 comments
Be the first person to recommend this.
Amo Pharma, a London-based privately held biopharmaceutical company, has entered into a collaboration agreement with Ranedis Pharmaceuticals, a Philadelphia-based privately held biopharmaceutical company, to progress the development of a drug candidate for rare genetic diseases, including certain lysosomal storage disorders and other diseases affecting the central nervous system. With the agreement, Ranedis has granted Amo an exclusive option to acquire the worldwide rights to the drug candidate, RND-001, during the collaboration period. RND-001 is a formulation of a histone deacetylase inhibitor (HDACi) whose properties allow for delivery of the molecule ...
0 comments
Be the first person to recommend this.
Megafine Pharma, a Mumbai, India-headquartered manufacturer of active pharmaceutical ingredients (APIs) and advanced intermediates, has received a Warning Letter from the US Food and Drug Administration (FDA) related to data integrity issues and deviations from current good manufacturing practices (cGMP) for drugs at its Gujara, India manufacturing facility. The violations were noted during an FDA inspection of the facility from September 19 to 23, 2016, and the agency reviewed Megafines response on October 14, 2016 and has acknowledged receipt of subsequent correspondence. During its inspection, the FDA observed that Megafine did not insure data integrity ...
0 comments
Be the first person to recommend this.
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Novartis and Pfizer. Editor's Note: This article is updated on a continuous basis for news announced from Wednesday March 8, 2017 to Tuesday March 14, 2017. FDA OKs Novartis Breast Cancer Drug for Combo Therapy The US Food and Drug Administration (FDA) has approved Novartis Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treating hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women. Kisqali ...
0 comments
Be the first person to recommend this.
The Pharmaceutical Inspection Co-operation Scheme (PIC/S), a non-binding, informal co-operative arrangement between regulatory authorities in the field of good manufacturing practice (GMP) of medicinal products for human or veterinary use, has issued an action plan that sets goals for the organization over the next two years. The key priorities for the 2017-2019 action plan include training, developing strategic development and communications, regulatory authority compliance, and harmonization of GMP/good distribution practice (GDP) guidance. Training remains PIC/S most important field of activity following the launch of the PIC/S Inspectorates Academy (PIA) ...
0 comments
Be the first person to recommend this.
Mylan has agreed to the terms of a global settlement with Roche and its subsidiary, Genentech, in relation to patents for Herceptin (trastuzumab), one of Roches top-selling cancer drugs with 2016 sales of CHF 6.78 billion ($6.73 billion). The settlement provides Mylan with global licenses for its biosimilar trastuzumab product. Mylan has been developing a biosimilar to Roches Herceptin with its partner, Bicon, a Bangalore, India-based biopharmaceutical company, for which the partners submitted a biologics license application with the US Food and Drug Administration in November 2016 , with an anticipated goal date set on Sept. 3, 2017 under the Biosimilar ...
0 comments
Be the first person to recommend this.
A roundup of the latest market developments from the pipelines of the pharmaceutical majors and other related news, featuring news from Allergan and Pfizer. Editor's Note: This article is updated on a continuous basis for news announced from Wednesday March 8, 2017 to Tuesday March 14, 2017. FDA Accepts Allergans Label Submission for Anti-Psychotic Drug The US Food and Drug Administration (FDA) has accepted for filing Allergan s supplemental new drug application for Vraylar (cariprazine), an anti-psychotic drug, seeking an addition to the current product label of new clinical data evaluating the drugs maintenance of efficacy in adults with schizophrenia. ...
0 comments
Be the first person to recommend this.
Dr. Reddys Laboratories is addressing a violations report issued by the US Food and Drug Administration (FDA) for Dr. Reddys formulation manufacturing facility in Duvvada, Visakhapatnam, India following an FDA audit of that facility that was completed on March 8, 2017, according to a company filing made with the Bombay Stock Exchange. According to the company filing, the FDA issued Dr. Reddys a Form 483 with 13 observations. An FDA Form 483 is issued at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are ...
0 comments