Topic: Pharmaceuticals

JD Supra Corporate Brief: Big Data, Green Trade, iPad Regulation, Ukraine Sanctions

On March 11, 1999, Infosys became the first Indian company to be listed on the NASDAQ stock exchange. Mo’ data mo problems… (Judy Selby at BakerHostetler) Going green + going global = going great! (King & Spalding) When is an iPad more than an iPad? When it’s an FDA regulated medical device, for starters… (Sharon… Read more »

FDA Proposes New Policy to Boost Development of Fixed-Combination Drug Products

“FDA’s new interpretation of these terms would result in a determination of 5-year [New Chemical Entity] exclusivity for each active ingredient in a drug product instead of the drug product as a whole.”  (Carlson Caspers) The Food and Drug Administration has proposed a policy change that should give combination therapies a shot in the arm.… Read more »

JD Supra Corporate Brief: Artificial Intelligence, Cybersecurity Framework, Safe Harbor, LIBOR Administrator

On this day in 1801, an electoral college tie was resolved when the House of Representatives named Thomas Jefferson President of the United States, and Aaron Burr Vice-President. Anybody else think that would have been an interesting outcome for the Bush v. Gore election? Robotics, artificial intelligence, and automation are transforming the workplace. So what… Read more »

JD Supra Corporate Brief: Cyber Attacks, China Regulations, Virtual Currencies, Religious Accommodation

We know how this turned out… On this day in 1876, both Alexander Graham Bell and Elisha Gray applies for a patent on the telephone. Worried you might be targeted for a cyber attack? Read this. Today… (Roberta Anderson and Katherine Blair at K&L Gates) China’s current regulatory environment continues to present new challenges for the pharmaceutical… Read more »

JD Supra Corporate Brief: Iran Sanctions, E-Communications Policies, UK Fracking, Union Elections

Our cure for the Monday morning blues? Two shots of espresso and the JD Supra Corporate Brief… Let’s be clear on this point: Iran is NOT open for business… (Amanda Blunt, Carrie Kroll, and Lindsay Meyer at Venable) More than 80% of business correspondence takes place via email. And that creates a lot of risk… Read more »

JD Supra Corporate Brief: State of the Union, Regulating the Insurance Industry, Tilting at Windmills, Reforming Corporate Taxes

And the rest is history: on this day in 1886, Karl Benz patented the first successful gasoline-powered automobile. President Obama’s 2014 State of the Union address: the JD Supra reader… (JD Supra Contributors) Here’s a look at the top regulatory issues for the insurance industry in 2014… (Chris Mosley, Hilary Rowen, and Matthew Vuolo; JD… Read more »

JD Supra Corporate Brief: CEO Divorces, Reverse Churning, IRS Guidance, Employee Benefits

Naughty? Nice? No matter: we won’t put coal in your stocking. Just the JD Supra Corporate Brief: Should the CEO’s divorce be reported in SEC filings? (Kerry Berchem at Akin Gump) The SEC is crunching a lot of data these days, and one of the things they’re looking for is reverse churning… (Daniel Nathan at… Read more »

FDA’s Proposed Rule on Generic Drug Labeling Could Sow Confusion and Chaos (and Lawsuits)

The FDA wants to give generic drug makers the same labeling authority as their branded peers. Attorneys Erin Bosman, James Huston, and Julie Park of Morrison & Foerster explain: [T]he U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule … in an effort to ‘create parity’ between brand-name and generic manufacturers for their… Read more »

JD Supra Corporate Brief: Shareholder Activism, Google Filters, Disappearing Goodwill, Fair Lending

Slow morning? Let the JD Supra Corporate Brief jumpstart your day: Public corporations aren’t the only ones who have to worry about shareholder activism – so do the country’s banks… (Skadden Arps) The law may be on his side, but erasing compromising photos of Max Mosley on the Internet will take more than a filter… Read more »

JD Supra Corporate Brief: Dual-Track Process, Conflict Minerals Disclosure, Forced-Placed Insurance, Insider Trading Risk

Need a break from the hustle and bustle of your morning commute? Just pull up the JD Supra Corporate Brief on your tablet, pop in your earbuds, and let the law news take you away… There are two reasons companies should pursue a dual-track mergers and acquisition and initial public offering process… (Cathy Birkeland at… Read more »

JD Supra Corporate Brief: Cyber Insurance, Mary Jo White, CEO Liabilities, Biosimilar Law

Happy Alaska Day! This is why you need cyber insurance… (BakerHostetler) How has Mary Jo White done in her first six months on the job? (Reed Smith) Yes, the CEO could be held liable for unpaid wages… (Baker Donelson) Sure, the shutdown is over, but the questions about paying furloughed contractors remain… (Morrison & Foerster)… Read more »

What All Multinationals Can Learn from the Glaxo China Trouble

“This is the first time that the Chinese have enforced their domestic anti-corruption laws against western corporations doing business in China. It makes clear that doing business the ‘old fashioned way’ in China through bribery and corruption will no longer be tolerated.” (Thomas Fox) The story is unfortunately all too common – major multinational accused… Read more »

JD Supra Corporate Brief: China Detentions, HIPAA Policies, Compounding Pharmacies, Club Deals

Sign up for email delivery of the JD Supra Corporate Brief, and you’ll never go hungry for reading material again! The key lesson for multinationals from China’s arrest and detention of four GSK employees? Update your anti-corruption programs… (K&L Gates) Worried that the Supreme Court’s ruling against “pay to delay” agreements in Actavis could expose… Read more »

JD Supra Corporate Brief: Drug Pricing in China, Corruption in Brazil, Climate Change in Congress, Antitrust Law in Europe

A Friday in July and you’re reading the JD Supra Corporate Brief? Does it get any better? China is questioning 60 pharmaceutical companies about their drug pricing (Dechert) Myriad is going on the litigation offensive to protect its BRCA1 and BRCA2 patents (MBHB) Even the ITC is targeting patent trolls… (Duane Morris) Companies operating in… Read more »

JD Supra Corporate Brief: EU Antitrust Fines, IRS Compliance Checks, NIST Security Guidelines, CFPB Rulemaking Agenda

Haven’t signed up for email delivery of the JD Supra Corporate Brief? Well, what are you waiting for? The EU’s first “pay-for-delay” fine is a hard pill to swallow for pharmaceutical manufacturers… (K&L Gates) The IRS has begun to conduct “compliance checks” of Section 457(b) plans… (McDermott Will & Emery) Is heightened scrutiny of the… Read more »