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SC refers 349 FDC medicines to Drug Advisory Board for relook
A bench said that the 349 FDCs were banned pursuant to the Kokate Committee report, by notifications of the central government under Section 26A of the Drugs Act. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 15, 2017 Category: Pharmaceuticals Source Type: news

Govt fixes ceiling prices of 849 formulations till Nov
Ceiling prices of 59 formulations were reduced by more than ​ 40 per cent with respect to maximum price: Govt (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 15, 2017 Category: Pharmaceuticals Source Type: news

Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines
​​Companies can make and sell the 349 contested fixed dose combination drugs (FDCs) while Drugs Technical Advisory Board (DTAB) deliberates on the issue. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 14, 2017 Category: Pharmaceuticals Source Type: news

SC asks drugs advisory body to decide fate of 349 banned combination medicines
​​Companies can make and sell the 349 contested fixed dose combination drugs (FDCs) while Drugs Technical Advisory Board (DTAB) deliberates on the issue. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 14, 2017 Category: Pharmaceuticals Source Type: news

Cadila gets USFDA nod for generic drug to treat Parkinson's
The Ahmedabad-based firm also received final approval from the USFDA to market Nitrofurantoin Capsules USP, used for treating acute uncomplicated urinary tract infections, in the US market. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 14, 2017 Category: Pharmaceuticals Source Type: news

Lupin gets USFDA nod for generic contraceptive tablets
The company has received final approval from the US Food and Drug Administration (USFDA) to market Tydemy, which is a generic version of Bayer HealthCare Pharmaceuticals' Safyral Tablets, Lupin said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 14, 2017 Category: Pharmaceuticals Source Type: news

Torrent Pharma completes acquisition of Unichem Laboratories Ltd
he acquisition will accelerate Torrent's presence in the chronic space especially in the high growth segments of Indian Pharma market like Cardiology, Diabetology and Gastroenterology. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 14, 2017 Category: Pharmaceuticals Source Type: news

PerkinElmer may invest over $100 million in India by 2022
Over the next 3-5 years, the company is mulling investment of over $100 million in India for these purposes, according to him. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 13, 2017 Category: Pharmaceuticals Source Type: news

CCI starts probe on alleged price fixing of key anti diabetic drugs
Emcure also did not respond to an email query as of press time while USV remained unreachable for a comment. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 13, 2017 Category: Pharmaceuticals Source Type: news

JB Chemicals & Pharma gets USFDA nod for hypertension tablets
"The USFDA has approved the company's supplementary Abbreviated New Drug Application (ANDA) for Atenolol tablets USP 25mg, 50mg and 100 mg," J B Chemicals& Pharmaceuticals said in a BSE filing today. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 13, 2017 Category: Pharmaceuticals Source Type: news

Alembic Pharmaceuticals gets USFDA go-ahead for bladder drug
According to IMS December 2016 data, Darifenacin extended release tablets had an estimated market size of USD 64 million. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 12, 2017 Category: Pharmaceuticals Source Type: news

Novo Nordisk India and Torrent Pharma expand their insulin manufacturing facility
Torrent Pharmaceuticals and Novo Nordisk began their partnership 25 years ago in 1992 with the manufacture and launch of insulin in 40 IU vials. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2017 Category: Pharmaceuticals Source Type: news

Granules' arm completes audit with USFDA
Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company completed its first audit from December 4-8, 2017 by the USFDA with one observation," the company said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2017 Category: Pharmaceuticals Source Type: news

Suven gets product patents from India, US
Suven Life said the granted claims of the patents are being developed as therapeutic agents and useful in treatment of cognitive impairment associated with neurodegenerative disorders. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2017 Category: Pharmaceuticals Source Type: news

Rhizen receives USFDA fast track designation for cancer drug
USFDA has granted Fast Track Designation for RP6530.. for the treatment of patients with relapsed/refractory peripheral T- cell lymphoma (PTCL)," Alembic Pharmaceuticals said in a BSE filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2017 Category: Pharmaceuticals Source Type: news

Mylan wants to capture chronic Hep B market
The drug was approved in India in November this year and is the “first” to be approved in eight years for the management of this infection here, Mylan added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2017 Category: Pharmaceuticals Source Type: news

Zydus gets USFDA nod for schizophrenia treatment drug
The company has got final approval from the USFDA to market the drug in the strengths of 25 mg, 50 mg, 100 mg and 200 mg, Zydus Cadila said in a BSE filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2017 Category: Pharmaceuticals Source Type: news

Glenmark Pharma begins clinical trial of anti-myeloma drug
The additional study objectives include assessment of biomarkers, immunogenicity and additional measures of anti- tumour activity, it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2017 Category: Pharmaceuticals Source Type: news

Lupin, Cadila recall drugs in US Market
Zydus Pharmaceuticals USA Inc, arm of Cadila Healthcare, is also recalling 19,812 bottles of Paroxetine tablets in the strength of 30 mg from the US market. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 7, 2017 Category: Pharmaceuticals Source Type: news

Lupin, Cadila Healthcare recall drugs in US
Zydus Pharmaceuticals USA Inc, arm of Cadila Healthcare, is also recalling 19,812 bottles of Paroxetine tablets in the strength of 30 mg from the US market. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 7, 2017 Category: Pharmaceuticals Source Type: news

Serum Institute to launch 4 vaccines, enter US, Europe markets
The company sells its products in 147 countries and is the largest vaccines manufacturer by dosage globally with 1.2 billion doses per annum. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 7, 2017 Category: Pharmaceuticals Source Type: news

Sanofi continues to seek clinical trial waiver in India for controversial dengue vaccine
Phase 3 trials are the last phase of clinical trials that a company conducts before it receives approval to market the drug here. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2017 Category: Pharmaceuticals Source Type: news

Shared latest data on dengue vaccine with authorities: Sanofi
Yesterday, the Philippines government ordered an investigation into the immunisation of more than 7.3 lakh children with the company's dengue vaccine. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2017 Category: Pharmaceuticals Source Type: news

This company is ready to flood the US with cheap HIV drugs
US patents on key components for some important HIV therapies are poised to expire starting in December and Laurus Labs -- the Hyderabad, India-based company which owns the facility -- is gearing up to cash in. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2017 Category: Pharmaceuticals Source Type: news

New Zealand billionaire backs Indiabulls Pharma
Incorporated in 2016, the company currently has nearly 300 products under its stable, some of which have been introduced in India for the first time to meet patients ’ needs. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2017 Category: Pharmaceuticals Source Type: news

USFDA nod for cancer biosimilar is a big triumph: Kiran Mazumdar Shaw
After initial hiccups with the US and EU drug regulators, Shaw said this approval signifies India and her company ’s capability in developing complex drugs. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2017 Category: Pharmaceuticals Source Type: news

Indiabulls Pharma receives Rs 155 crore investment from Clermont Group
The investment will bolster the company ’s ambition of becoming a leading provider of healthcare products and services in India and be amongst the top 10 players in the coming decade. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2017 Category: Pharmaceuticals Source Type: news

India fines Monsanto for delays in answering anti-trust questions
Monsanto responded to CCI's queries in August, but only after eight reminders issued between April 2016 and May this year, the watchdog's November order showed. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2017 Category: Pharmaceuticals Source Type: news

New expert committee to consult on drug pricing, new drug launches
According to DoP's latest order, the committee would deliberate and make recommendations on the claims of pharmaceutical cos about additional therapeutic features associated with any drug formulation and bulk drug. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2017 Category: Pharmaceuticals Source Type: news

Biosimilar drug by Mylan, Biocon gets USFDA approval
Biosimilar drugs are identical copy of highly complex biologic drugs that claim to have the same efficacy as that off the innovator ’s version. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2017 Category: Pharmaceuticals Source Type: news

USFDA okays Mylan, Biocon's biosimilar of cancer drug Herceptin
Ogivri is the first USFDA approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the US. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2017 Category: Pharmaceuticals Source Type: news

Dr Reddy's gets nod to restart exports to EU from Vizag plant
The company, however, did not elaborate on the observations which were made by the regulator related to violations of good manufacturing practises (GMP). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 30, 2017 Category: Pharmaceuticals Source Type: news

Piramal acquires Digeplex from Shreya Lifesciences
"We believe Digeplex and its associated brands are a strategic fit for our portfolio that will help us move closer towards our stated objective," executive director Nandini Piramal said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 30, 2017 Category: Pharmaceuticals Source Type: news

Cipla gets WHO nod to sell TB preventing drug in HIV patients
Q-TIB is a novel fixed dose combination in a single tablet and it is for the first time that such a combination has been made available in the world. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 30, 2017 Category: Pharmaceuticals Source Type: news

Healthcare's dilemma: Balancing public needs with business sense
With the scrutiny over quality and affordability of healthcare becoming a big issue, the question of balancing public needs with commercial aspirations have polarised the industry. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 29, 2017 Category: Pharmaceuticals Source Type: news

Government needs proactive approach to boost pharma sector: Industry
The Indian pharmaceutical industry, with current market size of USD 27.57 billion is expected to reach USD 55 billion by 2020 growing at a CAGR of 15.92 per cent. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 29, 2017 Category: Pharmaceuticals Source Type: news

Securities class action lawsuit served on Dr Reddy's in US
The lawsuit alleged that the company made materially false and/or misleading statements or omissions in connection with its corporate quality system, it had added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 29, 2017 Category: Pharmaceuticals Source Type: news

Nigeria new attraction for Indian pharma firms
With more than 60 per cent of the population falling within the working age of 15-64 years, this young workforce will be able to support the growth of Nigeria's services sector, McKinsey said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 29, 2017 Category: Pharmaceuticals Source Type: news

One in 10 medicines in developing countries is substandard or falsified: WHO
WHO has received reports of substandard or falsified medical products ranging from cancer treatment to contraception. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 28, 2017 Category: Pharmaceuticals Source Type: news

Glenmark Pharma gets 7 observations from USFDA for Baddi unit
Glenmark said its Baddi unit contributes approximately 10 per cent of the revenue of the US sales. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 28, 2017 Category: Pharmaceuticals Source Type: news

How India can make cheap and quality medicines available to all
They could procure medicines from any manufacturer complying with WHO current good manufacturing practices (cGMP) but would incur heavy penalties for repeated stock-outs. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 28, 2017 Category: Pharmaceuticals Source Type: news

Regulatory actions won't stop growth of emerging markets, says Sanofi EVP
Emerging markets account for 7% of Sanofi ’s global revenues, driven by its limited product in rare diseases, diabetes and oncology segments. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 27, 2017 Category: Pharmaceuticals Source Type: news

Zydus gets USFDA nod for seizure, migraine drug
Zydus Cadila has more than 170 approvals and has so far filed over 310 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 27, 2017 Category: Pharmaceuticals Source Type: news

New chemotherapy delivery hits precise target
Having got a US patent in April this year, Kumar claims his precision-targeted drug delivery system is market-ready. “I think we will go into production in nine months. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 26, 2017 Category: Pharmaceuticals Source Type: news

Sun Pharma recalls two lots of diabetes drug due to microbial contamination
According to US FDA, a Class II recall occurs in a situation where use of or exposure to the product may lead to temporary or medically reversible adverse health consequences. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 25, 2017 Category: Pharmaceuticals Source Type: news

More life-saving medicines to become cheaper by as much as 53%
The National Pharmaceutical Pricing Authority (NPPA) on Friday fixed the maximum prices of 36 medicines and revised the ceiling prices of 15 others. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 24, 2017 Category: Pharmaceuticals Source Type: news

GST makes ‘orphan drugs’ prices soar
These high-value ‘orphan’ drugs used in bone marrow transplant, classical Hodgkin Lymphoma, Crohn’s disease and melanoma. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 24, 2017 Category: Pharmaceuticals Source Type: news

Biocon introduces oncologic biosimilar KRABEVA in India
The biosimilar product will be used for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers in India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 23, 2017 Category: Pharmaceuticals Source Type: news

Will Indian drug exports to other countries get stuck in EU ports?
In 2008, 17 shipments (16 from India and one from China) were detained in Europe on grounds of infringement of intellectual property. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 23, 2017 Category: Pharmaceuticals Source Type: news

Strides arm gets USFDA nod for altitude sickness tablets
In a BSE filing, it said Strides Pharma Global Pte. has received approval from the United States Food and Drug Administration (USFDA) for Acteazolamide tablets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 22, 2017 Category: Pharmaceuticals Source Type: news