A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

(Reuters) - The U.S. Food and Drug Administration on Monday approved Tesaro Inc’s drug, niraparib, for the treatment of recurrent ovarian cancer.

Epithelial ovarian, fallopian tube or primary peritoneal cancer affects the tissue covering the ovary or lining of the fallopian tube or abdominal wall.</s>REUTERS: The U.S. Food and Drug Administration on Monday approved Tesaro Inc's drug, niraparib, for the treatment of recurrent ovarian cancer.

Epithelial ovarian, fallopian tube or primary peritoneal cancer affects the tissue covering the ovary or lining of the fallopian tube or abdominal wall.</s>Shares of Dishman Pharmaceuticals jumped as much as 20 per cent to hit all-time high as the company has got FDA nod for cancer drug.

The company's partner Tesaro Inc has got U. Food and Drug Administration (FDA) nod for ovarian cancer drug Niraparib.

Niraparib kills cancer cells by inhibiting the production of proteins called PARPs, which help repair damaged DNA strands.

Research firm Dolat Capital says this drug has the potential to become very large given it is the first PARP inhibitor available as of now.

"We expect revenues from this molecule to Dishman can be anywhere between $40-80 million,'' Dolat Capital says.

More than 2.2 million shares traded, over twice their 30-day moving average.

Dishman stock was up 7.3 per cent this year as of Monday's close.</s>Nov 24 The U.S. Food and Drug Administration said it had approved Eli Lilly & Co's Portrazza, in combination with two forms of chemotherapy, to treat patients with a type of lung cancer.

However, the treatment will need to carry a "boxed warning" that flags potential fatal risks, including cardiac arrest and sudden death. (1.usa.gov/1NbzJZ8)

A 1,093-patient clinical trial showed that patients who received Portrazza, along with chemotherapy drugs gemcitabine and cisplatin, survived an average of 11.5 months compared with 9.9 months for those who received only chemotherapy treatments.

The FDA's approval on Tuesday comes about four months after an advisory panel to the agency recommended the drug be cleared for sale along with the warnings.

Lung cancer is the leading cause of cancer death in the United States, with about 221,000 new diagnoses and 158,000 deaths so far in 2015.

Portrazza is approved to treat advanced squamous non-small cell lung cancer, the most common type of lung cancer.

It is not approved for the second type of non-small cell lung cancer, non-squamous cell.

Eli Lilly's shares were down 1.5 percent at $83.43 in early afternoon trading on the New York Stock Exchange. (Reporting by Ankur Banerjee and Rosmi Shaji in Bengaluru; Editing by Anil D'Silva and Ted Kerr)</s>The U.S. Food and Drug Administration said it approved the first copycat versions of Otsuka Pharmaceutical Co Ltd's antipsychotic drug Abilify.

Generic versions of the drug have been approved for mental illnesses such as bipolar disorder and schizophrenia. (1.usa.gov/1EO2DvW)

The FDA said it granted approval for generics from four companies including Teva Pharmaceutical Industries Ltd. (Reporting by Vidya L Nathan in Bengaluru; Editing by Saumyadeb Chakrabarty)</s>According to the Food and Drug Administration (FDA), there are approximately 9 women whose deaths were caused by a unique cancer of the blood after they had breast implants.

You can look at the FDA’s full report on BIA-ALCL here.

Just previous year, WHO (World Health Organization) said that the ALCL was classified into a different diagnosis according to health officials from France and Australia, who made efforts in tracking and assessing the link between the ALCL and breast implants.

Breast augmentation is the second most popular cosmetic procedure among women, after liposuction. It’s the top cosmetic surgery performed in the U.S. with 290,467 procedures in 2016, according to the American Society of Plastic Surgeons. The cancer is very rare with 300 cases over 10 years or longer to develop.

And the FDA says it is easily treated if caught early enough. “Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation”.

Breast implants may be a good idea for some, but it could cause a rare form of cancer called anaplastic large cell lymphoma (ALCL) to form.

“At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk”, the agency said.

Of the 231 cases that were reported, 28 of these were patients who had implanted a smooth surface while the other 203 had the ones with a textured surface.

The FDA reported that as of February 1 it had received 359 medical device reports of BIA-ALCL, including nine deaths. Both saline and silicone gel-filled implants were associated with the cancer. “They come in different sizes and shapes and have either smooth or textured surfaces (shells)”, it says.

Ultimately, the FDA says that they will continue to gather additional information and report on significant findings.

The reason for the texturing of the implants is for prevention of capsular contracture.

In most cases, the cancer was found during surgery to remove or replace an implant after the women reported pain, lumps and swelling around it.

People who are considering getting the surgery should do their research and discuss with their surgeon about the risks and benefits between textured- and smooth-surfaced implants, the FDA advised.

The cancer is not breast cancer, the FDA emphasized.

People who already have breast implants should monitor their implants any changes and get routine screenings such as mammograms or MRIs as recommended by their doctors, the agency suggested. Doctors from around the globe are expected to submit disease cases that have resulted from complications of breast implants in patients.</s>The FDA approved a new drug to treat eczema aniaostudio / Getty Images

It’s approved for people with atopic dermatitis, a catchall term for itchy skin caused by allergy.

It can be very unpleasant.

“The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy,” the FDA says.

“Scratching leads to swelling, cracking, weeping clear fluid, and finally, coarsening and thickening of the skin.”

There are many treatments out there now, from simple skin lotions to steroid creams and immune suppressant drugs like tacrolimus. But none of these works for everybody, and the immune suppressant drugs can raise the risk of cancers such as lymphoma.

Dupixent is for the hard-core cases that aren’t helped by anything else.

It’s a monoclonal antibody — a targeted immune system drug — that inactivates two inflammatory compounds called interleukin 4 or IL-4, and IL-13. “By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis,” the FDA said in a statement.

Known generically as dupilumab, the drug can cause serious allergic reactions and eye inflammation. “The most common side effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling and itching,” the FDA notes.

The agency gave it both priority review and breakthrough therapy status, speeding it through the approval process.

Studies of about 2,000 people showed Dupixent injections resulted in clear skin or nearly clear skin for about two-thirds of those who tried it, and it reduced itching sharply in 40 percent.

“People with moderate to severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” Julie Block, president and CEO of the National Eczema Association, said in a statement provided by the company.

“Of the adults with uncontrolled moderate to severe atopic dermatitis in the United States, it is estimated that 300,000 are most in need of new treatment options,” Regeneron said.

In a nod to the sensitivity around drug prices, the company stressed that there is no single price for the drug.

“The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or</s>WASHINGTON, D.C. (AP) — The U.S. Food and Drug Administration says it has received reports of 9 deaths and more than 350 cases of a rare blood cancer linked to breast implants.

The FDA said Tuesday it now agrees with the World Health Organization, which concluded years ago this type of lymphoma can develop following breasts implants.

Concerns were first raised at the FDA in 2011, but the agency said then that there were too few cases to know if there was a connection.

The disease seems to occur more often with textured implants in the scar tissue near the implant and is associated with pain and swelling sometimes years after the surgery has healed.

The FDA said it can’t determine how many cases there are, but noted Australia has also reported three deaths.</s>The U.S. Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy.

"Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence. "Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation."

Epithelial ovarian, fallopian tube or primary peritoneal cancer is a cancer of the tissue covering the ovary or lining the fallopian tube or abdominal wall (peritoneum). The National Cancer Institute estimates that more than 22,000 women will be diagnosed with these cancers in 2017 and more than 14,000 will die of these diseases.

Zejula is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.

The safety and efficacy of Zejula were studied in a randomized trial of 553 patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who had received at least two prior treatments of platinum-based chemotherapy and who had experienced a complete or partial response to their most recent chemotherapy treatment. Patients were tested with an FDA-approved test to determine whether they had a specific gene mutation, called a deleterious or germline BRCA mutation. The trial measured the length of time the patients' tumors did not grow after treatment (progression-free survival) in patients with and without the mutation. The median progression-free survival for patients taking Zejula who had a germline BRCA mutation was 21 months compared to 5.5 months for the same patient population taking a placebo. The median progression-free survival for patients taking Zejula who did not have a germline BRCA mutation was 9.3 months compared to 3.9 months for the same patient population taking a placebo.

Common side effects of Zejula include low levels of red blood cells (anemia), low levels of blood platelets (thrombocytopenia), low levels of white blood cells (neutropenia or leukopenia), heart palpitations, nausea, constipation, vomiting, abdominal pain/swelling (distention), inflammation of the mucous membranes (mucositis), diarrhea, indigestion (dyspepsia), dry mouth, fatigue, decreased appetite, urinary tract infection, liver problems (AST/ALT elevation), muscle pain (myalgia), back pain, joint pain (arthralgia), headache, dizziness, unusual taste sensation (dysgeusia), insomnia, anxiety, cold-like symptoms (nasopharyngitis), trouble breathing (dyspnea), cough, rash and high blood pressure (hypertension). Zejula is associated with serious risks, such as hypertension, severe increase in blood pressure (hypertensive crisis), bone marrow problems (myelodysplastic syndrome), a type of cancer of the blood called acute myeloid leukemia and low levels of blood cells in the bone marrow (bone marrow suppression).Women who are pregnant or breastfeeding should not take Zejula because it may cause harm to a developing fetus or a newborn baby.

The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations.

Zejula also received Orphan Drug designation specifically for its use in treating recurrent epithelial ovarian cancer. This designation provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Zejula to Tesaro, Inc.</s>Feb 3 The U.S. Food and Drug Administration on Tuesday said it had approved Pfizer Inc's experimental breast cancer drug Ibrance, a regulatory decision that came more than two months earlier than expected.

Many analysts have considered the drug, whose chemical name is palbociclib, to be one of the most promising medicines in Pfizer's development pipeline, with potential for multibillion-dollar annual sales. (Reporting by Ransdell Pierson; Editing by David Gregorio)
The U.S. FDA approves Tesaro's ovarian cancer drug, Niraparib.