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Wednesday, April 3, 2013
Mylan, Biocon help market generic insulin drugs
PITTSBURGH -- Mylan Inc. said Wednesday it will help market generic versions of some of the biggest-selling insulin drugs in the world under a new agreement with Biocon Ltd., India's largest biotechnology company by revenue.
The companies did not disclose terms of the deal.
Mylan said it will have the right to develop Biocon's generic version of Sanofi's drug Lantus, Eli Lilly and Co.'s Humalog, and Novo Nordisk AG's NovoLog. Mylan said combined worldwide sales of Lantus, Humalog and NovoLog totaled about $11.5 billion in 2012.
Mylan and Biocon will share some of the costs involved in developing the generics, and Mylan will have the exclusive rights to sell them in the U.S., the European Union and European Free Trade Association, Canada, Australia, and New Zealand. The companies will share profits on those sales. Mylan will have the right to work with Biocon to sell the drugs in some other markets.
Mylan shares rose 6 cents to $28.86 during regular trading, then fell a penny to $28.85 in after-hours trading.
Raylan and Winona and Boyd And Ava: ‘Justified’ On What It Means To Be A Man
This post discusses plot points from the February 12 episode of Justified.
The last two episodes of Justified have been full of advancements in the search for Drew Thompson, the vanished man who holds the key to the arrival of cocaine in Harlan County. But I have to admit, I haven’t been particularly engaged by this season of the show’s central mystery. Instead, my favorite parts of Justified this season have involved an evolving juxtaposition between U.S. Marshal Raylan Givens (Tim Olyphant) and his oldest friend and enemy, Boyd Crowder (Walton Goggins). The show’s always played with the marginal differences between the two men, contrasting Raylan’s competence with Boyd’s charisma. But now the show is playing with the sense of who’s the good man and who’s the bad one by contrasting their relationships with the women in their lives, Winona, who is pregnant with Raylan’s child, but determined that they can’t make a go of it as a couple, and Ava, who is newly-engaged to Boyd.
In last week’s episode, Raylan simultaneously tried to prove that he could be a responsible figure in Winona and their child’s life, while simultaneously undermining the impression that he was capable of living up to his obligations. When he found out Winona had found a job, Raylan insisted “You don’t have to do that. I’ve been picking up some extra money doing side jobs.” But the side jobs he was doing were under the table, rather than sanctioned by the Marshal Service, and based on events earlier in the season, it’s not exactly clear that Raylan’s going to be able to hold on the money he picks up working on the side, given the general lawlessness of Harlan. Trying to be cute, Raylan told the child “Hey little one, you got to lose the tail. Come out and read about your daddy in the paper.” Winona couldn’t resist pointing out that “this baby lost its tail a little while ago, just so you know.” Raylan tried to defend himself, insisting “I’m a little behind on my homework, but the point is, I’m going to be here for you and the baby.” But it was an idea he immediately proved he can’t live up to, heading off as soon as he got a call from the office, and leaving Winona to her appointment.
Much of what defines Raylan as a Marshal is his competence: he’s cool in a standoff, knows how to shoot out an airbag to distract a suspect, has a good sense of what pressure points to put on a teenage girl run wild. But knowing how to fire a gun and being possessed of the confidence to insist on the correctness of your decisions isn’t the same thing as being a partner or a father. Raylan’s pulled to a sphere where his knowledge is useful and his decision-making is central, where his partners largely defer to him, and he’s familiar with the processes that arbitrate his decisions that are judged to be bad. Parenthood and relationship-building offer him none of those consolations or escape hatches—they’re roles that require compromise, sitting around and listening, accepting that someone else’s experiences and interpretations of events take precedence over your own.
Boyd, on the other hand, has never been able to operate as a lone wolf in the way that Raylan has. A gang leader needs followers. A pastor needs a congregation. And crime lords need lieutenants. And all of those roles require some level of engagement with and management of other people’s emotions. When Ava confronted him in last night’s episode, he was obliged to respond, both as her employer and as her lover. “I’m struggling here, Boyd. You asked me earlier if I loved you. You know the answer to that’s yes. I didn’t lose any sleep over Devil. Certainly not over Delroy. But Ellen May being in the ground, it’s tearing me apart,” Ava explained to him. “It doesn’t keep me from seeing her face every time I close my eyes. I have and I will do anything for you, Boyd Crowder. But if we’re going to continue down this road, I got to know where we’re headed.”
When Boyd proposed to Ava it was tremendously romantic precisely because it wasn’t just a response to Ava being under tremendous stress, but the revelation that he’s been thinking about what she wants, and what he wants for them, all along.
“It’s a down payment on a house, Ava, any place you want it. Maybe it’ll even be a place with a view like this,” he told Ava of the cash in the box he presented to her. “In three generations time, we’ll be a family name. No one will think about their kid and a Crowder kid playing together…I know this ain’t exactly how most people do it, professing their love over a pile of cash. But the way I see it, Ava, you and me aren’t like most people. Ava, the love of my life, the apple of my eye, will you marry me?”
While Raylan’s still struggling with showing up and staying showed up on a day-to-day-basis, Boyd’s been planning and executing a plan for his future. Raylan may do less harm in the conduct of his trade than Boyd does in his. But often these days, Boyd comes across as the better man.
Slow approvals put India's drug trials industry at risk
MUMBAI/NEW DELHI, Feb 13 (Reuters) - Slower government approval for testing new medicines is threatening India's aspirations to be a fast-growing, low-cost hub for clinical trials, and has prompted some drugs firms to shift operations elsewhere, adding to their costs.
While India's drug regulator and the health ministry's medical research body deny any slowdown, interviews by Reuters with pharmaceutical companies, lobby groups, industry watchers and healthcare activists tell a different story.
Drugs firms complain that sluggish bureaucracy in New Delhi and a lack of legal clarity on how to conduct clinical trials have created a climate of regulatory uncertainty in the market.
That has been exacerbated by a high profile case in the Supreme Court between the regulator and health activists, who allege that companies used poor people as human "guinea pigs" to trial unsafe drugs without their knowledge or consent, and without proper state scrutiny. They have asked the court to suspend all trials for new chemical entities (NCEs) - substances that may be turned into a new drug after tests.
Drugmakers, speaking on condition of anonymity, say the case has made government officials more cautious in considering new approvals, asking more questions and being tougher to convince.
"The situation was never quite easy in India," said Siddhant Khandekar, a healthcare analyst at ICICI Direct brokerage in Mumbai. But with the Supreme Court case "the scenario has worsened and getting new approvals has become more time consuming," he said.
"ANYWHERE IN THE WORLD"
The legal case has prompted Piramal Enterprises Ltd , a $1.8 billion Indian drugmaker, to look abroad to trial new drugs, its vice chairperson Swati Piramal told Reuters, warning that India was losing its "innovation edge".
The approval time for initiating drug trials in India typically stretches to 6-8 months, compared to just 28 days in Europe and Canada, said Piramal. "Post the Supreme Court case, certainly companies like us will look anywhere in the world to see if we get good trials," she said.
Lupin Ltd, India's fourth-largest drugmaker by sales, said it had wanted to conduct an NCE trial in India last year, but the $5 billion firm eventually went overseas as the approval process was too slow and made more uncertain by the ongoing Supreme Court case.
"I think the intention is right but the implementation is so slow, that it's hampering in the near term," said Nilesh Gupta, Lupin's group president. "For NCEs in particular in India, the process is extremely long."
ECCRO, a contract research organisation that focuses on India, sees global drugmakers turning to Russia and Brazil for their trials as they struggle to get approval in India.
But moving drugs trials abroad could raise the cost for Indian companies. The $20,000 cost of trialling a drug in the United States is 10-20 times that in India, said Deepak Malik, a healthcare analyst at Emkay Global.
INDUSTRY "AT RISK"
The relatively low cost of conducting trials and a fast-growing population of 1.2 billion should make India an attractive destination for companies to carry out tests. It is already a generic drug-making powerhouse whose exports to Latin America and Africa have earned it the sobriquet as "the developing world's pharmacy".
The domestic drugs trial market was worth about $485 million in 2011, according to consultants Frost & Sullivan, who predict that could double to $1 billion by 2016.
But the regulatory fog surrounding clinical trials means Asia's third-largest economy has failed to fulfil its potential to become a testing hub, companies and analysts said. Less than 1.5 percent of global trials take place in India, according to the Indian Society for Clinical Research (ISCR).
"We are concerned by delays in approval of clinical trials, and ambiguity in the processes, over the past two years," said a spokesman for MSD, the local unit of U.S. drugmaker Merck & Co .
ADDED LAYER
Two groups of activists filed cases last year alleging firms illegally conducted trials, exploiting poor people by testing potentially harmful drugs on them. The cases are being heard simultaneously in the Supreme Court.
"Putting patients first is at the heart of everything we do, and our clients share this same commitment to patients and their safety," said Quintiles, a clinical research services provider to various drugmakers around the world, including India.
"In the event of an injury in a clinical trial, the need for compensation for the patient and/or their dependent(s) is taken very seriously, and is handled by the sponsor of the trial in accordance with all applicable regulations and guidelines," Quintiles said in an emailed response to a Reuters query for this article.
The Supreme Court last month ordered the health ministry to supervise all clearances for new drug trials, creating an added layer of decision-making.
Two activists told Reuters they believed the cases had stymied new drug trial approvals as senior government officials were too nervous to take decisions. "Unofficially they have decided not to sanction new clinical trials," said activist Amulya Nidhi.
However, G.N. Singh, the drugs controller general of India, said there had been no changes to the approvals process. "There hasn't been any halt in approving new clinical trials," Singh told Reuters. "We cannot suddenly wake up one day and decide 'Ok, no more clinical trials in this country'."
V.M. Katoch, the head of the state-run Indian Council of Medical Research (ICMR), which advises the drugs regulator on approvals, also disputed that approval times had slowed.
Referring to the allegations made in the Supreme Court, he said trials conducted without the patient's consent were a small number of aberrations. "That creates the impression that everything is wrong all around, which is not true actually," he said. "The ethical practices every year have become stronger and stronger."
However, Katoch acknowledged that recent negative publicity around drug trials in India had put the government "on the defensive" for a while.
Statement by Vice President Biden on the Violence Against Women Act
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For Immediate Release February 12, 2013 Statement by Vice President Biden on the Violence Against Women ActToday, the Senate passed the Violence Against Women Act with overwhelming bipartisan support. This law has been incredibly effective and I hope the House will vote without delay to renew the law so that we can continue to assist victims of domestic violence and sexual assault and hold offenders accountable for their crimes.
Delay isn’t an option when three women are still killed by their husbands or boyfriends every day. Delay isn’t an option when countless women still live in fear of abuse, and when one in five have been victims of rape. This issue should be beyond debate – the House should follow the Senate’s lead and pass the Violence Against Women Act right away. This is not a Democratic or Republican issue – it’s an issue of justice and compassion.
President Obama issued an Executive Order directing federal departments and agencies to use their existing authorities to provide better cybersecurity for the Nation, efforts that will by necessity involve increased collaboration with the private sector.
February 13, 2013 5:15 PM ESTOpen for Questions: The State of the Union and the EconomyAlan Krueger, Chairman of the Council of Economic Advisers, answered questions from the public about President Obama's State of the Union Address in an “Open for Questions” session moderated by Yahoo! Finance. Check it out below.
February 13, 2013 4:55 PM ESTFirst Lady Michelle Obama hosts a “Beasts of the Southern Wild” Movie Workshop for StudentsThe stars of the Oscar-nominated drama joined Mrs. Obama to help teach students about the hard work required to create a beautiful movie.
view all related blog posts ul.related-content li.views-row img {float: left; padding: 5px 10px 0 0;}ul.related-content li.view-all {padding-bottom: 3em;} Stay ConnectedFacebookTwitterFlickrGoogle+YouTubeVimeoiTunesLinkedIn Home The White House Blog Photos & Videos Photo Galleries Video Performances Live Streams Podcasts Briefing Room Your Weekly Address Speeches & Remarks Press Briefings Statements & Releases White House Schedule Presidential Actions Legislation Nominations & Appointments Disclosures Issues Civil Rights Defense Disabilities Economy Education Energy & Environment Ethics Foreign Policy Health Care Homeland Security Immigration Taxes Rural Urban Policy Veterans Technology Seniors & Social Security Service Snapshots Women Violence Prevention The Administration President Barack Obama Vice President Joe Biden First Lady Michelle Obama Dr. Jill Biden The Cabinet White House Staff Executive Office of the President Other Advisory Boards About the White House Inside the White House Presidents First Ladies The Oval Office The Vice President's Residence & Office Eisenhower Executive Office Building Camp David Air Force One White House Fellows White House Internships Tours & Events Mobile Apps Our Government The Executive Branch The Legislative Branch The Judicial Branch The Constitution Federal Agencies & Commissions Elections & Voting State & Local Government Resources En español Accessibility Copyright Information Privacy Policy Contact USA.gov Developers Apply for a Job Palin: Obama should make ‘gesture of condolence’ for slain SEAL sniper
Former Republican vice presidential candidate Sarah Palin said Monday that President Obama should make a “gesture of condolence” for slain Navy SEAL Chris Kyle. Kyle, a veteran of the Iraq war and reportedly the deadliest sniper in American military history, who was killed earlier this month by another veteran at a shooting range.
"We're surrounded today by American patriots here in Texas — by Chris' fellow veterans and active duty warriors," she posted to Facebook. "In honor of them, I hope our commander in chief pays his respects in some gesture of condolence for their comrade in arms who sacrificed so much to keep him and all of us safe."
Palin, who will attend Kyle’s funeral in Dallas, said she and her husband "find it sad to see that flags aren't flying at half staff for this American hero."
Kyle met the Palins when helping to consult on security operations for the premiere of a documentary about the former Alaska governor that debuted in 2011. Palin’s husband, Todd, also appeared on an NBC reality series with the Navy veteran."We may never know to what extent Chris kept us free or how many lives he saved by his brave actions in the line of fire. But his fellow warriors know how important he was," Palin wrote.
Kyle, 38, served in five combat tours in Iraq and was thought to have killed 160 people during his service. He and another veteran were killed at a shooting range Feb. 2 by a former Marine who was thought to be suffering from combat-related mental health issues.
View Comments‘Game of Thrones’ Returns Soon: What Are You Hoping For?
It’s felt a bit like we’ve been living through one of Westeros’s infamous winters, at least when it comes to the dwindling supply of good television, so I’m looking forward to the return of Game of Thrones like a Brother of the Night’s Watch awaiting a raven of the appropriate coloring from the Citadel:
There’s not much here to see yet—Tyrion’s scar is probably the biggest change this lets us see. I understand why it would have been prohibitive to really get rid of Peter Dinklage’s nose to match up the damage Tyrion suffers during the Battle of the Blackwater in the books, but I do regret the preservation of his general handsomeness. Readers of the books may share my feelings about how that will affect our perception of events coming down the pike. For both readers and people who are only watching the show, what are you looking forward to and hoping for in season three? As a member of the former category, I have to admit I’m looking forward to seeing how the show starts to diverge from the novels, if only because I think that some of the story lines that are being changed and trimmed will give us clues about what’s going to happen in George R.R. Martin’s yet-to-be-completed novels, and which plotlines are just red herrings, and thus, for the purposes of television, dispensable.
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