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Women's Health

EMD Serono wins FDA nod for redesigned pen injector

November 13, 2017 By Sarah Faulkner

EMD Serono

Merck KGaA‘s biopharma biz, EMD Serono, said today that it won FDA approval for a redesigned version of its Gonal-f RFF Redi-ject pen injector. The device, which was first approved in 2013, is designed to inject follitropin alfra to induce ovulation and pregnancy in oligo-anovulatory women. The newly-designed pen was evaluated in a simulated-use study involving […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat, Women's Health Tagged With: emdserono, Merck

Teva closes Plan B emergency contraception sale in $2.3B restructuring effort

November 3, 2017 By Sarah Faulkner

Teva Pharmaceutical

Teva Pharmaceuticals (NYSE:TEVA) said today that it closed the $675 million cash sale of its Plan B One-Step product and emergency contraception assets to Foundation Consumer Healthcare. The move is part of Teva’s efforts to restructure its business, narrowing its focus on CNS and respiratory conditions. The company also plans to divest of its oncology and […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat, Women's Health Tagged With: Teva Pharmaceuticals

Agile Therapeutics touts late-stage trial for once-weekly contraceptive patch

October 31, 2017 By Sarah Faulkner

Agile Therapeutics (NSDQ:AGRX) touted data today from a Phase III trial of its once-weekly, low-dose hormonal contraceptive patch, Twirla. The study showed that women experienced mean decreases in length of bleeding and spotting episodes, the Princeton, N.J.-based company reported. Women taking Twirla reported a gradual decrease in the mean total number of bleeding or spotting […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat, Women's Health Tagged With: agiletherapeutics

Teva reintroduces generic Depo-Provera contraceptive in U.S.

September 25, 2017 By Sarah Faulkner

Teva Pharmaceutical

Teva Pharmaceuticals (NYSE:TEVA) said today that it is reintroducing the generic equivalent to the Depo-Provera contraceptive in the U.S. The injectable medroxyprogesterone acetate suspension brought in $211 million in sales this year in the U.S., according to the Jerusalem-based pharma giant. “This reintroduction brings an additional product to a market that was previously lacking in options,” Hafrun […]

Filed Under: Featured, Pharmaceuticals, Wall Street Beat, Women's Health Tagged With: Teva Pharmaceuticals

Study: Women with esophageal cancer fare better than men

September 19, 2017 By Sarah Faulkner

Hospital

The survival rate for esophageal cancer is, according to Dr. K. Robert Shen, bleak. Last year, there were 17,000 Americans diagnosed with the disease and nearly 16,000 of them died, the Mayo Clinic cardiothoracic surgeon told Drug Delivery Business News. “It’s almost reached an epidemic,” Shen said. “It doesn’t get a lot of airplay and […]

Filed Under: Featured, Oncology, Pharmaceuticals, Women's Health Tagged With: Mayo Clinic

Teva sells off the rest of its women’s health assets in $2.5B deal

September 18, 2017 By Sarah Faulkner

Teva Pharmaceutical

After the company divested its Paragard intrauterine device assets for $1.1 billion in cash last week, Teva Pharmaceuticals (NYSE:TEVA) announced today that it plans to sell off the rest of its global women’s health biz. Combined with proceeds from its Paragard deal, the sale of Teva’s global women’s health assets will total $2.48 billion, the company […]

Filed Under: Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat, Women's Health Tagged With: Teva Pharmaceuticals

Theraclion PI details breast cancer immunotherapy, ultrasound combo

September 11, 2017 By Sarah Faulkner

Theraclion

The co-lead investigator for a metastatic breast cancer trial combining Theraclion‘s focused ultrasound technology and immunotherapy discussed the design and rationale of the study, the France-based company reported today. Dr. David Brenin, chief of breast surgery at the University of Virginia School of Medicine, said that although immuno-oncology has been gaining steam as a way to […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Immunotherapy, Oncology, Wall Street Beat, Women's Health Tagged With: Theraclion

Aequus touts proof-of-concept trial for anti-nausea patch

September 7, 2017 By Sarah Faulkner

aequus pharmaceuticals

Aequus Pharmaceuticals (CVE:AQS) touted data today from an initial proof-of-concept study of its long-acting, transdermal anti-nausea patch, AQS1303. The patch, which combines pyridoxine hydrochloride and doxylamine succinate, is intended to treat nausea and vomiting associated with pregnancy. The oral form of pyridoxine hydrochloride, Diclegis, is dosed up to four times a day. The single-dose comparative bioavailability […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Women's Health Tagged With: aequuspharmaceuticals

Federal judge dismisses faulty birth control suit against Merck

August 25, 2017 By Sarah Faulkner

Merck

A Maine federal judge tossed out a woman’s lawsuit against Merck (NYSE:MRK), after she claimed that the company’s Nexplanon birth control implant allegedly failed to keep her from becoming pregnant. Kayla Doherty filed the suit in April 2015, seeking damages related to the costs of raising a child as a single mother and costs related to […]

Filed Under: Drug-Device Combinations, Featured, Implants, Legal News, Pharmaceuticals, Wall Street Beat, Women's Health Tagged With: Merck

Inovio tops Q2 sales estimate by $4m

August 9, 2017 By Sarah Faulkner

Inovio Pharmaceuticals

Shares in Inovio Pharmaceuticals (NSDQ:INO) rose today after the pharmaceutical company beat expectations on Wall Street with its second quarter results. The Plymouth Meeting, Penn.-based company posted a net loss of -$9.5 million on sales of $20.4 million for the 3 months ended June 30, for bottom-line growth of 49% compared with the same period last […]

Filed Under: Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Oncology, Wall Street Beat, Women's Health Tagged With: Inovio Pharmaceuticals

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