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Sarah Faulkner

Clearside Biomedical prices $85m underwritten offering

March 8, 2018 By Sarah Faulkner

Clearside Biomedical

Clearside Biomedical (NSDQ:CLSD) priced 6,538,462 shares of its common stock at $13.00 apiece in an $85 million underwritten public offering that’s expected to close early next week. The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients […]

Filed Under: Drug-Device Combinations, Featured, Funding Roundup, Optical/Ophthalmic, Pharmaceuticals, Wall Street Beat Tagged With: Clearside Biomedical

Senate bill looks to block tribal patent deals with pharma

March 8, 2018 By Sarah Faulkner

Allergan

Months after Allergan (NYSE:AGN) struck a controversial patent deal with a Native American tribe in New York, lawmakers are angling to make sure that it can’t happen again. Sens. Tom Cotton (R-Ar), Claire McCaskill (D-Mo) David Perdue (R-Ga), Joni Ernst (R-Ia) and Pat Toomey (R-Pa) introduced a bill this week that would prevent patent owners from […]

Filed Under: Drug-Device Combinations, Featured, Legal News, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Allergan, Mylan

Facing legal woes and SEC probe, Ocular Therapeutix posts mixed Q4

March 8, 2018 By Sarah Faulkner

Ocular Therapeutix

Shares in Ocular Therapeutix (NSDQ:OCUL) rose this morning after the company beat expectations on Wall Street with its fourth quarter earnings, but missed analysts’ sales estimates. The company is facing a slew of class action suits from investors, as well as a probe by the Securities and Exchange Commission regarding its post-surgical pain relief implant, Dextenza. […]

Filed Under: Drug-Device Combinations, Featured, Legal News, MassDevice Earnings Roundup, Optical/Ophthalmic, Pharmaceuticals, Surgical, Wall Street Beat Tagged With: Ocular Therapeutix

Valeritas takes on multiple daily insulin injections with wearable V-Go device

March 8, 2018 By Sarah Faulkner

Valeritas V-Go device

There are millions of Americans with Type II diabetes and many of them take multiple daily injections of insulin, using two injection pens – one for mealtime insulin and one for insulin throughout the day. But studies have found that people with Type II diabetes are willing to skip insulin injections if they have to […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: Sanofi-Aventis, Valeritas Inc.

Delcath inks supply deal with Tillomed Laboratories in Europe

March 7, 2018 By Sarah Faulkner

Delcath Systems

Delcath Systems (NSDQ:DCTH) said today that it inked a commercial supply deal with Tillomed Laboratories in Europe. According to the deal, Tillomed Labs is slated to provide Delcath with melphalan – the drug used in Delcath’s hepatic Chemosat delivery system. In Europe, the drug-device combo is approved to treat liver cancer. “We are particularly pleased to […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Oncology, Pharmaceuticals, Wall Street Beat Tagged With: Delcath Systems Inc.

Sen. McCaskill: Teva is “stonewalling” Senate investigation into opioid crisis

March 7, 2018 By Sarah Faulkner

capitol hill

Sen. Claire McCaskill (D-Mo.) said that Teva Pharmaceuticals (NYSE:TEVA) is “stonewalling” a Senate probe into the the role that opioid manufacturers have in the nation’s opioid crisis. In the senator’s initial inquiries with the generic drugmaker, McCaskill requested an array of documents detailing arrangements between Teva and its customers, as well as internal reviews of pharmacies […]

Filed Under: Featured, Legal News, Pain Management, Pharmaceuticals, Wall Street Beat Tagged With: Teva Pharmaceuticals

Clearside Biomedical floats $75m public offering

March 7, 2018 By Sarah Faulkner

Clearside Biomedical

Clearside Biomedical (NSDQ:CLSD) plans to offer $75 million in shares of its common stock in an underwritten public offering. The Alpharetta, Ga.-based company is slated to use the funds to prepare and submit an application to the FDA for its suprachoroidal eye drug as a treatment for patients with macular edema associated with non-infectious uveitis. Clearside […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Funding Roundup, Optical/Ophthalmic, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Clearside Biomedical

Patent board upholds AgaMatrix’s CGM patents in Dexcom IP spat

March 6, 2018 By Sarah Faulkner

gavel

The legal back and forth between Dexcom (NSDQ:DXCM) and AgaMatrix over the companies’ continuous glucose monitoring IP dates back to March of 2016, when AgaMatrix launched a patent infringement lawsuit against the San Diego, Calif.-based manufacturer in the U.S. District Court of Oregon. Later that year, Dexcom filed for inter parters review with the Patent Trial […]

Filed Under: Diabetes, Featured, Legal News, Wall Street Beat Tagged With: agamatrix, DexCom Inc., waveformtechnologies

Adamis Pharma’s EpiPen alternative succeeds in human factors study

March 6, 2018 By Sarah Faulkner

Adamis Pharmaceuticals

Adamis Pharmaceuticals (NSDQ:ADMP) has positioned its emergency allergy treatment as a cheaper alternative to Mylan‘s (NSDQ:MYL) EpiPen device. The company has also set out to prove that its epinephrine injector is easy to use, even by people using an auto-injector for the first time. Data from a human factors study conducted by Adamis were presented this week […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Respiratory, Wall Street Beat Tagged With: adamispharmaceuticals, Mylan

FDA updates Opdivo label to include four-week dosing option

March 6, 2018 By Sarah Faulkner

Bristol-Myers Squibb

The FDA approved a label update for Bristol-Myers Squibb (NYSE:BMY) Opvido cancer drug, giving patients the option to receive 480-mg infused every four weeks instead of 240-mg every two weeks. The PD-1 inhibitor was also cleared for shorter, 30-minute infusions across its approved indications, according to the biopharmaceutical company. “From the introduction of our first immuno-oncology […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Immunotherapy, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Bristol-Myers Squibb Co.

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