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Sarah Faulkner

West Pharmaceutical boosts its analytical services with new technology

May 17, 2018 By Sarah Faulkner

West Pharmaceutical

West Pharmaceutical Services (NYSE:WST) has expanded its analytical services capabilities with new equipment to help address the pharmaceutical industry’s packaging and drug-delivery concerns, the company said today. West specifically highlighted its addition of an ion mobility quadrupole time-of-flight mass spectrometer – an instrument that combines chromatography, ion mobility and mass spectrometry. The company also added a […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: West Pharmaceutical Services

Here are the pharma companies accused of blocking generic competition

May 17, 2018 By Sarah Faulkner

Pills

To prove a generic drug is as safe and effective as the branded version, pharmaceutical companies have to hand over upwards of 1,000 doses of the product to a generic developer. But if the manufacturer creating the generic drug cannot get its hands on enough sample, the development and testing process slows down. It could […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Wall Street Beat Tagged With: Actelion Pharmaceuticals, Celgene, FDA, Gilead Sciences, GlaxoSmithKline plc, Johnson & Johnson, Novartis, Valeant Pharmaceuticals

Cerus lands additional $15m in government funding

May 17, 2018 By Sarah Faulkner

Cerus Corp.

Cerus (NSDQ:CERS) landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority, bringing the total potential value of its deal to $201 million. The expanded agreement is designed to support additional clinical trials of the company’s Intercept blood transfusion technology. Cerus’ Phase III […]

Filed Under: Cardiovascular, Clinical Trials, Featured, Funding Roundup, Surgical, Wall Street Beat Tagged With: Cerus Corp.

FDA approves first non-opioid treatment for opioid withdrawal symptoms

May 17, 2018 By Sarah Faulkner

FDA

The FDA today approved the first non-opioid treatment designed to help manage the symptoms of opioid withdrawal in adults. The drug, Lucemyra, isn’t a treatment for opioid use disorder, the agency noted. Instead, it is meant to be used as part of a broader plan to help adults manage their symptoms when they stop using […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: FDA

Bayer wins second approval in China for Eylea eye drug

May 17, 2018 By Sarah Faulkner

Bayer

Bayer (ETR:BAYN) said today that its eye drug, Eyelea, was approved by the Chinese authorities to treat patients with wet age-related macular degeneration. The pharmaceutical giant’s aflibercept injection is already cleared in China to treat visual impairment due to diabetic macular edema. Age-related macular degeneration accounts for 8.7% of all blindness, according to Bayer – that’s […]

Filed Under: Featured, Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Bayer AG, Regeneron

Medtronic launches study of drug-eluting stent as treatment for bifurcation lesions

May 16, 2018 By Sarah Faulkner

Medtronic

Medtronic (NYSE:MDT) today launched a study to evaluate the safety and efficacy of its Resolute Onyx drug-eluting stent for the treatment of bifurcation lesions in patients with coronary artery disease. The medtech giant said that bifurcation lesions make up nearly 20% of all percutaneous coronary interventions. The assessment of DES tech in this patient group is part […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Medtronic

HHS secretary calls on drug companies to ‘stop the price hikes’

May 16, 2018 By Sarah Faulkner

capitol hill

After President Donald Trump’s drug pricing speech last week was deemed a “non-event” by analysts, all eyes turned to the secretary of the U.S. Dept. of Health & Human Services, Alex Azar, to see what the former pharma executive viewed as the administration’s top concerns. Azar called on the industry to “stop the price hikes” […]

Filed Under: Featured, Pharmaceuticals, Wall Street Beat Tagged With: Eli Lilly & Co.

Reva touts first implant of bioresorbable scaffold in Turkey

May 16, 2018 By Sarah Faulkner

Reva Medical

Reva Medical (ASX:RVA) said today that the company launched its Fantom bioresorbable scaffold in Turkey. There are nearly 100 hospitals performing cardiac catheterizations in Istanbul, according to Reva. The San Diego, Calif.-based company highlighted Turkey as an important market for bioresorbable technologies, noting that it has a commercial distribution deal in the country with Kardionet Healthcare and […]

Filed Under: Drug-Device Combinations, Featured, Implants, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Reva Medical

Aerie seeks FDA nod for Roclatan once-daily eye drop

May 15, 2018 By Sarah Faulkner

Aerie Pharmaceuticals - updated

Aerie Pharmaceuticals (NSDQ:AERI) said today that it submitted a new drug application to the FDA for its once-daily eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. The company’s Roclatan product is a fixed-dose combination of two drugs – netarsudil and latanoprost. Aerie’s latest eye drug was proven to be safe and […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Aerie Pharmaceuticals

PolarityTE aims to ‘wage war on skin grafts’ with regenerative tech

May 15, 2018 By Sarah Faulkner

PolarityTe

PolarityTE wants to eliminate skin grafts with its platform of regenerative technology. The Utah-based biotech is still new to the industry, but co-founders Denver Lough and Ned Swanson are betting that their company can take on the clinical standard of care for wound management. “No other product, whether it be a drug, a biologic device, […]

Filed Under: Clinical Trials, Featured, Regenerative Medicine, Wall Street Beat, Wound Care Tagged With: polarityte

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