May - August, 2014
Ipca and Oncobiologics Create Strategic Biosimilars Partnership
Ipca Laboratories Ltd., India and Oncobiologics, Inc., USA announced today the creation of a two-part alliance for the development, manufacture and commercialization of biosimilar monoclonal antibody products. Under the first part of the agreement, Ipca will in-license and commercialize biosimilar products for the India and associated markets. These products will be developed by Oncobiologics to US FDA and EU regulatory standards for global commercialization. Initial manufacturing will occur in the USA by Oncobiologics and later by Ipca in India. http://www.pharmpro.com/news/2014/06/ipca-and-oncobiologics-create-strategic-biosimilars-partnership
Cheap Drug Greatly Boosts Prostate Cancer Survival
A cheap, decades-old chemotherapy drug extended life by more than a year when added to standard hormone therapy for men whose prostate cancer has widely spread, doctors reported Sunday. Men who received docetaxel, sold as Taxotere and in generic form, lived nearly 58 months versus 44 months for those not given the drug, a major study found.
Worldwide Pharma Industry Marketing Investment Flat in 2013
Cegedim Strategic Data (CSD) has released results on pharmaceutical marketing investments for full year 2013. Worldwide, industry investment in pharmaceuticals sales force and marketing channels remained flat in 2013, at just under [Eur]85 billion constant US dollars. Notably, the leading 10 multinationals ranked by promotional expenditure, all reduced investment during the 12 months to December 2013.
Ranbaxy Decision Shows Why FDA Reluctant to Rely on European Inspections
The European Medicines Agency (EMA) Thursday said it was lifting a ban on a Ranbaxy Laboratories plant in India whose products the FDA also has banned and is not ready to accept.
FDA Panel Advises Against More Clinical Trials for Opioid Constipation Drugs
An FDA panel advised the agency against requiring more large clinical studies for the cardiovascular risks of drugs that treat opioid-induced constipation, relieving drugmakers like AstraZeneca ($AZN), Salix Pharmaceuticals ($SLX) and others from bearing the burden of further clinical safety trials. http://www.fiercepharma.com/story/fda-panel-advises-against-more-clinical-trials-opioid-constipation-drugs/2014-06-12
After 4-year Benicar Review, FDA Slaps Aside Heart-Risk Worries
The FDA finally wrapped up its review of Benicar safety. After four years of sifting data, the agency says it found “no clear evidence” that Daiichi Sankyo’s blockbuster blood pressure drug increased the risk of heart attack. But the agency will require new safety-related data on Benicar’s official label. http://www.fiercepharma.com/story/after-4-year-benicar-review-fda-slaps-aside-heart-risk-worries/2014-06-25
Researchers Link Brain Gene to Kidney Cancer
A gene known to control brain growth and development is heavily involved in promoting clear cell renal cell carcinoma, the most common form of kidney cancer, researchers from Mayo Clinic in Florida are reporting. http://www.dddmag.com/news/2014/06/researchers-link-brain-gene-kidney-cancer
FDA Outlines Expectations for Drug Compounders, Including Outsourcing Facilities
The U.S. Food and Drug Administration issued several policy documents regarding compounded drug products for human use, as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. The policy documents consist of a draft interim guidance, a proposed rule, a final guidance, and two revised requests for nominations for the bulk drug substances lists. http://www.pharmpro.com/news/2014/07/fda-outlines-expectations-drug-compounders-including-outsourcing-facilities
Hospira Completes Acquisition of Orchid’s API Manufacturing and R&D Facility
Hospira has completed the acquisition of an active pharmaceutical ingredient (API) manufacturing facility and an associated research and development (R&D) facility from Orchid Chemicals & Pharmaceuticals Ltd., an Indian pharmaceuticals company, for approximately $218 million, after settling prior advances of approximately $30 million. http://www.pharmpro.com/news/2014/07/hospira-completes-acquisition-orchids-api-manufacturing-and-r-d-facility
Missouri Governor Vetoes Health Navigator Limits
Missouri Gov. Jay Nixon vetoed legislation Monday that would have limited who could work in the state as a health insurance guide and blamed a national conservative group for injecting an error into the model legislation. http://www.pharmpro.com/news/2014/07/missouri-governor-vetoes-health-navigator-limits
WHO: Basic Hygiene Can Help Prevent MERS Spread
A World Health Organization official on Thursday urged millions of Muslims making the pilgrimage to Mecca, Saudi Arabia, to exercise basic hygiene as mass gatherings pose risks of spreading the Middle East respiratory syndrome. http://www.pharmpro.com/news/2014/07/who-basic-hygiene-can-help-prevent-mers-spread
Salix Pharmaceuticals to Combine with Cosmo Technologies to Form Salix Pharmaceuticals, plc
Salix Pharmaceuticals, Ltd. and Cosmo Pharmaceuticals S.p.A. today announced a definitive merger agreement under which Salix will combine with Cosmo Technologies Limited (“Cosmo Tech”), a subsidiary of Cosmo. Under the terms of the agreement, Salix will become a wholly-owned subsidiary of Irish domiciled Cosmo Tech. http://www.pharmpro.com/news/2014/07/salix-pharmaceuticals-combine-cosmo-technologies-form-salix-pharmaceuticals-plc
Compounding Pharmacy Oversight Changes Signed
Gov. Deval Patrick on Thursday signed a law he said would address a “gray area” between state and federal oversight of the pharmacies. The measure includes new licensing and labeling requirements and steps up fines for violations of state rules. It also reorganizes the board that oversees pharmacies and requires the board’s inspectors to be trained in sterile and non-sterile compounding practices.
Galderma Finalizes Major Expansion in Aesthetic and Corrective Dermatology in the U.S. and Canada
Galderma S.A. announced that it has gained full rights to distribute Restylane, Perlane, Emervel, Sculptra and Dysport from Valeant Pharmaceuticals International, Inc. The expansion into aesthetic and corrective dermatology in the U.S. and Canada completes Galderma’s global skin health footprint and extends its leadership in aesthetic medicine worldwide. http://www.pharmpro.com/news/2014/07/galderma-finalizes-major-expansion-aesthetic-and-corrective-dermatology-us-and-canada
FDA Designates Opioid Overdose Treatment for Fast Track Development Program
The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process. AntiOp and the FDA may also be able to employ additional tools to expedite the FDA review process such as “rolling submission,” whereby AntiOp may submit portions of the new drug application (NDA) in a staged NDA submission process.
Anthera Pharmaceuticals Acquires Sollpur for Exocrine Pancreatic Insufficiency From Eli Lilly
Anthera Pharmaceuticals today announced that it has acquired Sollpura (liprotamase), a novel investigational Pancreatic Enzyme Replacement Therapy (“PERT”) from Eli Lilly and Company. http://www.pharmpro.com/news/2014/07/anthera-pharmaceuticals-acquires-sollpur-exocrine-pancreatic-insufficiency-eli-lilly
LEO Pharma and KLOX Technologies Strike Global Dermatology Deal
LEO Pharma A/S and KLOX Technologies Inc. (KLOX) have entered into a worldwide license and joint venture agreement, excluding Canada, to further develop and commercialize KLOX’s BioPhotonic technology platform in dermatology, which includes a CE approved treatment for moderate to severe acne. LEO Pharma will also make an equity investment in KLOX.
FDA Weighs Cancer Risk of Fibroid Removal Devices
Surgeons developed the technique as an alternative to traditional surgery, which requires a larger incision that often results in more bleeding and longer hospital stays. But the FDA convened a two-day meeting this week after concluding that the risk of accidentally spreading undetected cancer to other organs may be far more common than previously thought.
Chiltern Acquires Ockham - Companies Merge Operations
Chiltern and Ockham, two full-service contract research organizations (CROs), today announce that Chiltern has acquired 100% of Ockham and that the companies will merge their operations. http://www.pharmpro.com/news/2014/07/chiltern-acquires-ockham-companies-merge-operations
CDC Director Admits Safety Problems at Germ Labssourcing Facilities
He director of the Centers for Disease Control and Prevention acknowledged Wednesday that systemic safety problems have for years plagued federal public health laboratories that handle dangerous germs such as anthrax and bird flu..
Teva Completes Acquisition of Labrys
The acquisition of Labrys brings to Teva LBR-101, a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), which is currently in Phase IIb clinical trials for prevention of chronic and episodic migraine. Teva’s acquisition of LBR-101 complements the recent acquisition of ZECUITY ®, a novel iontophoretic patch that delivers sumatriptan via the skin for the acute treatment of migraine, and positions Teva to compete for leadership in the treatment and prevention of migraine.
FDA Warns of Compounded Drug Recall by Texas Firm
The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals’ plant in Temple, Texas. The inspections revealed production problems in several lots of drugs that were supposed to be sterile.
Agents Get Subsidized ‘Obamacare’ Using Fake IDs
Undercover investigators using fake identities were able to secure taxpayer-subsidized health insurance under President Barack Obama’s health care law.
Study: 10M Have Gained Coverage Through Health Law
A new study estimates that more than 10 million adults gained health insurance by midyear as the coverage expansion under President Barack Obama’s law took hold in much of the country. http://www.pharmpro.com/news/2014/07/study-10m-have-gained-coverage-through-health-law
Obama Wants Limits on US Company Mergers Abroad
Staking out a populist stand ahead of the midterm elections, President Barack Obama on Thursday demanded “economic patriotism” from U.S. corporations that use legal means to avoid U.S. taxes through overseas mergers. http://www.pharmpro.com/news/2014/07/obama-wants-limits-us-company-mergers-abroad-0
FDA Gives OK to Purdue Pharma’s Targiniq ER
The Food and Drug Administration has approved Purdue Pharma’s Targiniq ER, an opioid painkiller with abuse-deterrent properties. The FDA said Wednesday that Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) is the second extended-release/long-acting opioid analgesic with approved labeling describing its abuse-deterrent capabilities.
Metastatic Brain Tumor Treatment Could Be on the Horizon
A new Cincinnati Cancer Center (CCC) study, published in the advance online edition of the journal Oncotarget, provides hope that previously studied SapC-DOPS could be used for treatment of brain cancer that has spread. http://www.dddmag.com/news/2014/07/metastatic-brain-tumor-treatment-could-be-horizon
EU Regulator: Morning-After Pill OK for All Women
A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer’s declaration that the drugs didn’t work in women weighing more than 80 kilograms (176 pounds).
FDA Approves Malignant Hyperthermia Drug
U.S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. http://www.dddmag.com/news/2014/07/fda-approves-malignant-hyperthermia-drug
Reoviruses: The Discovery of Their Potential in Cancer Therapeutics
Reoviruses are benign viruses with an important property: they are oncolytic, meaning they are capable of infecting and destroying many kinds of cancer cells. The story of how this discovery was made is an exciting one. http://www.dddmag.com/articles/2014/07/reoviruses-discovery-their-potential-cancer-therapeutics
Roche Buying Seragon for Up to $1.7B
Roche Holding AG said its U.S.-based biotech company Genentech has agreed to acquire American biotechnology firm Seragon Pharmaceuticals Inc. for up to $1.725 billion in cash and contingency payments. http://www.dddmag.com/news/2014/07/roche-buying-seragon-17b
House Passes Bill to Speed FDA’s Sunscreen Approvals
The House passed legislation Monday to require the Food and Drug Administration to speed approval of new types of sunscreen in the wake of a regulatory backlog that has stalled their introduction. http://www.skinandallergynews.com/news/news/single-article/house-votes-to-speed-sunscreen-approvals/66eb81090b9f2782c98d3d99ee997307.html
Johnson & Johnson Recalls Laparoscopic Surgery Power Morcellators
Johnson & Johnson’s Ethicon division, the manufacturer of laparoscopic power morcellators, announced that it is recalling all of the devices they have manufactured. According to news reports, J&J is getting out of the power morcellator business. Doctors and hospitals have expressed concerns about the risk of laparoscopic power morcellators spreading cancer during laparoscopic uterine fibroid removal. http://fortworth.legalexaminer.com/medical-devices-implants/johnson-johnson-recalls-laparoscopic-surgery-power-morcellators/
U.S. Ebola Virus Patient Being Treated in Atlanta Faces Crucial Days
An American infected with Ebola in Liberia was being treated and monitored in the U.S. on Sunday, as doctors worked to provide care in what will be a crucial few days in his attempt to recover from the deadly disease. http://online.wsj.com/articles/cdc-chief-seeks-to-allay-ebola-fears-1407081530
Low T Side Effects Androderm Patch Death Lawsuit
The family of Alvin Harris, from Virginia has recently filed a wrongful death lawsuit against Androderm patch manufacturers. The plaintiffs claim that warnings about the risk of heart attacks, strokes and blood clots side effects with the testosterone replacement therapy were insufficient.