TB Alliance seeks clinical trial waiver for Pretomanid drug
Pretomanid, a new oral treatment is a shorter more convenient option for people with extensively drug resistant (XDR) TB. The dossier for getting approval for the drug has been filed with the drug regulatory authorities. India not only records highest number of TB cases but also bears the maximum burden of XDR TB patients. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 1, 2019 Category: Pharmaceuticals Source Type: news

Stempeutics Research receives patent for critical limb ischemia treatment method
"The US patent is for the method of treating ischemia by administering pooled allogeneic mesenchymal stromal cells," Stempeutics Research said in a statement. Critical Limb Ischemia is a severe blockage in the arteries which results in reduced blood flow which in turn may result in poor quality of life. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 1, 2019 Category: Pharmaceuticals Source Type: news

Sanofi inks pact with Unitaid; to reduce TB drug Rifapentine price by 70%
In a landmark development, global biopharmaceutical company Sanofi will lower the price of Rifapentine, a critically important drug used to prevent tuberculosis (TB), as part of the agreement with Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria, an official release said on Thursday. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 31, 2019 Category: Pharmaceuticals Source Type: news

RFL scam: Court extends till November 14 judicial custody of ex-Fortis promoters Malvinder, Shivinder
In another setback for former Fortis Healthcare promoters a Delhi court on Thursday extended judicial custody of Malvinder Singh and his brother Shivinder for allegedly misappropriating funds of Religare Finvest Ltd. Metropolitan Magistrate Deepak Sherawat also extended the judicial custody of three others, Sunil, Kavi and Anil, till Nov 31. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 31, 2019 Category: Pharmaceuticals Source Type: news

Processes must be robust; merely being better no longer an option: Siddharth Mittal, Managing Director, Biocon
We have a very good track record on GMP compliance. We are taking a digital journey in strengthening our quality system, which will help us be dependent on systems and processes and less on people, says Siddharth Mittal, MD, Biocon. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 30, 2019 Category: Pharmaceuticals Source Type: news

Prices of cancer, cardiac drugs may be slashed
This is a departure from the existing mechanism in which all essential medicines automatically go under price control. The Standing National Committee will decide which medicines should be available in adequate numbers and assured quality. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 29, 2019 Category: Pharmaceuticals Source Type: news

GSK's tuberculosis vaccine shows promising results
The new vaccine, known as M72/AS01E, was tested at 11 sites in Kenya, South Africa and Zambia in adults whose blood tests showed they had latent TB. The study revealed that the vaccine could cut the number of people developing TB by half. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 29, 2019 Category: Pharmaceuticals Source Type: news

Niti Aayog proposes separate regulator for medical devices
The ministry had issued a draft notification saying that all medical devices would come under the category of drugs from December 1 and would be regulated under the Drugs& Cosmetics Act. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 29, 2019 Category: Pharmaceuticals Source Type: news

Jubilant Cadista Inc recalls 63,216 bottles of erosive esophagitis tablets
The reason for the recall is "CGMP Deviation: Presence of dark brown discoloration on edges of tablets," USFDA said. The ongoing voluntary recall is a class II recall, the report said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 28, 2019 Category: Pharmaceuticals Source Type: news

Biocon number six in top 10 Global Biotech Employers ranking for 2019
Biocon continues to be the only company from Asia to feature on the prestigious US-based 'Science' magazine's annual 'Science Careers Top 20 Employers' list, since its debut in 2012. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 28, 2019 Category: Pharmaceuticals Source Type: news

Mumbai pharma company gets licence for breakthrough TB drug
A global non-profit drug developer TB Alliance has tied up with domestic company Macleods Pharmaceuticals to develop and commercialise its ‘breakthrough’ drug Pretomanid in high-burden countries, including India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 28, 2019 Category: Pharmaceuticals Source Type: news

Macleods Pharma USA Inc recalls 31,968 bottles of diabetes drug in US
Macleods Pharma USA Inc has declared Pioglitazone Hydrochloride tablets used for treatment of diabetes in America to be superpotent which was manufactured in Baddi, Himachal Pradesh. The product was shipped to 8 distributors in US, USFDA reported. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 28, 2019 Category: Pharmaceuticals Source Type: news

Dr Reddy's gets 4 observations from USFDA for Srikakulam plant
"The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a Form 483 with four observations," said Dr Reddy's. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 26, 2019 Category: Pharmaceuticals Source Type: news

Dr Reddy ’s recalled all batches of heartburn drug from US
Ranitidine is commonly prescribed as an antacid and the NDMA impurity scandal had rocked Indian generic makers present in US who were one of the largest suppliers of the drug. After FDA ’s cautionary note, several Indian cos had to recall this product. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 25, 2019 Category: Pharmaceuticals Source Type: news

Johnson and Johnson under the lens again
J&J insists that its talc is safe. It has been under scrutiny in India since 2013. The company went to court and got its licence back. In 2018, it came under scrutiny once again when India ’s drug regulator decided to investigate baby powder. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 25, 2019 Category: Pharmaceuticals Source Type: news

Cipla may raise bar with digital therapeutics push
The company has taken early steps to brace itself for a paradigm shift in the role of drug companies, from pill makers to care givers and therapeutic service providers. The new role of a pharma company is being envisioned. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 25, 2019 Category: Pharmaceuticals Source Type: news

Cadila Healthcare gets USFDA nod for Haloperidol Decanoate injection
Haloperidol is used in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette syndrome. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 24, 2019 Category: Pharmaceuticals Source Type: news

Alembic Pharma gets USFDA nod for Desonide Ointment
Desonide Ointment, 0.05 per cent, is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 24, 2019 Category: Pharmaceuticals Source Type: news

Aurobindo Pharma gets USFDA nod for its expectorant tablets
The company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture its generic Guaifenesin extended-release tablets in the strengths of 600 mg and 1,200 mg. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 24, 2019 Category: Pharmaceuticals Source Type: news

Centre likely to cap veterinary drug prices
Centre is mulling to cap the prices of a new catalogue of veterinary drugs and vaccines in a bid to boost the Prime Minister's new initiative to control livestock diseases. The move could impact companies in the animal healthcare business in India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 23, 2019 Category: Pharmaceuticals Source Type: news

Strides Pharma gets USFDA inspection report for Alathur unit with no adverse observations
The company said the company's formulations unit in Alathur was inspected by the US Food and Drug Administration (USFDA) in August without any adverse observations. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 23, 2019 Category: Pharmaceuticals Source Type: news

Dr Reddy's recalls all its ranitidine products in US
NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 23, 2019 Category: Pharmaceuticals Source Type: news

Batches of Strides' Ranitidine tablets now available for sale in Australia
Out of the 135 batches of Ranitidine which were tested by TGA, 109 batches were found to have an NDMA level at or above the acceptable limit of 0.3 ppm. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 23, 2019 Category: Pharmaceuticals Source Type: news

Huge gap in private, government hospital charges under Ayushman: Study
Over 18,550 hospitals are empanelled under the govt ’s flagship health insurance scheme. Of this, 54% are private hospitals and the rest are public. The scheme is designed to provide free annual health insurance cover of Rs 5 lakh to 50 crore people. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 21, 2019 Category: Pharmaceuticals Source Type: news

Granules India gets USFDA nod for allergy treatment drug
Granules India said it has received approval for Fexofenadine Hydrochloride tablets. The approved product is bio-equivalent to the reference listed drug product (RLD), Allegra Allergy Tablets, 60 mg and 180 mg, of Sanofi-Aventis US LLC. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 21, 2019 Category: Pharmaceuticals Source Type: news

Online pharmacies to grow to $3.7 billion by 2022: CLSA
According to CLSA, there are several e-pharmacies operating currently but Netmeds, Pharmeasy, Medlife and 1mg have emerged as the key players with a pan-India reach. These companies have cumulatively raised close to $400 million since starting out. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 18, 2019 Category: Pharmaceuticals Source Type: news

Mylan working with DCGI to launch new TB drug in India
Mylan will be in a position to launch the product in India soon after receiving approvals from DCGI," Mylans global president and executive director Rajiv Malik said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 15, 2019 Category: Pharmaceuticals Source Type: news

Drug regulator steps up monitoring of ranitidine
The US FDA announced an update of testing of NDMA in ranitidine, warning manufacturers not to use a high-temperature test for NDMA as it generates high levels of the impurity. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 14, 2019 Category: Pharmaceuticals Source Type: news

Sun Pharma launches Cequa to treat dry eye disease in US
One of the company's wholly-owned subsidiaries has commercialised Cequa 0.09 per cent in the US, Sun Pharma said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 14, 2019 Category: Pharmaceuticals Source Type: news

Torrent Pharma recalls 74k bottles of hypertension drug from US
As per the report, Torrent Pharma Inc is recalling 17,088 bottles of Losartan Potassium /Hydrochlorothiazide tablets, USP 50mg/12.5mg from the same markets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 13, 2019 Category: Pharmaceuticals Source Type: news

‘Karma’ catches up with Ranbaxy's Malvinder and Shivinder Singh
As India cleans up one of the world ’s worst bad-loan mess, govt is cracking down on defaulting borrowers. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 12, 2019 Category: Pharmaceuticals Source Type: news

Daiichi-Ranbaxy case: Radha Soami chief claims in HC don't owe money to Singh brothers
Dhillons told the court that RHC Holding has made false claims that they owe money to the company. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 11, 2019 Category: Pharmaceuticals Source Type: news

Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA
The FDA conducted a cGMP (Current Good Manufacturing Practices) inspection at the Unit 7 manufacturing facility from September 19-27 this year. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 10, 2019 Category: Pharmaceuticals Source Type: news

Chinese growth shot ’s some years away for pharma companies
For most Indian pharmaceutical cos venturing into China, market is still restricted to licensing of speciality products& monetisation may take time. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 10, 2019 Category: Pharmaceuticals Source Type: news

Patients' group opposes stent categorisation
In April 2015 and January 2018, expert committees examining the request for separate categories for 'innovative' stents had decided that there was no case for sub-categorisation due to the lack of clinical evidence of superiority of the 'innovative' stents over other drug eluting stents. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 10, 2019 Category: Pharmaceuticals Source Type: news

India mulls radical change for faster vaccine availability
Halving time for approval, sidestepping animal testing of vaccines is on the cards. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 9, 2019 Category: Pharmaceuticals Source Type: news

Daiichi-Ranbaxy case: HC asks Radha Soami head, 54 others to deposit Rs 6,000 crore
Money will also be recovered from former Religare Enterprises chief Sunil Godhwani and his brother Sanjay Godhwani. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 8, 2019 Category: Pharmaceuticals Source Type: news

Regulator may go over the counter to tackle issue of drug overdose
As per the Nicholas Hall 2017 report, the Indian OTC market is expected to grow at a compounded annual growth rate (CAGR) of 9% to cross the $6.5 billion mark by 2026. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 7, 2019 Category: Pharmaceuticals Source Type: news

Single regulatory framework likely for all medical devices
Currently, only 23 categories of medical devices are regulated in India under the Drugs and Cosmetics (D&C) Act. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 5, 2019 Category: Pharmaceuticals Source Type: news

USFDA red flags Lupin for significant violations at MP unit
The USFDA said it had inspected the Unit 1 at the Mandideep facility of the company from November 26 to December 4, 2018. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 4, 2019 Category: Pharmaceuticals Source Type: news

Johnson Controls-Hitachi sets up global development center in Gujarat
The company has employed 150 engineers at this center for carrying out research and development, said Johnson Controls-Hitachi Air Conditioning CEO Franz Cerwinka. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 4, 2019 Category: Pharmaceuticals Source Type: news

Shield Healthcare acquires two entities for undisclosed sum
Following the acquisitions, Shield Healthcare aims to increase its presence in gynaecology and paediatrics, a company release said here on Thursday. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 3, 2019 Category: Pharmaceuticals Source Type: news

Lupin appoints Johnny Mikell as Global Head of Quality
He will be based out of the company's US offices and will lead the quality function globally and, will help steer the company towards enhanced standards of quality and compliance, Lupin said (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 3, 2019 Category: Pharmaceuticals Source Type: news

Lupin appoints Sreeji Gopinathan as its CIO
"Sreeji brings to Lupin over 20 years of significant domain expertise and global experience," Lupin said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 3, 2019 Category: Pharmaceuticals Source Type: news

Biocon, Mylan launch insulin biosimilar in Australia
The biotechnology major and pharmaceutical company Mylan N V announced the launch of their insulin biosimilar Semglee. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - October 3, 2019 Category: Pharmaceuticals Source Type: news

Mylan to invest $1 billion in India on capex in 6 years
Currently Mylan has 21 facilities and 15,000 employees working in India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 29, 2019 Category: Pharmaceuticals Source Type: news

DoP lists options to rationalise drug trade margins for Niti Aayog
In a meeting held earlier this month with Niti Aayog, DoP also suggested that trade margin on all formulations and dosages be capped at 100%. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 28, 2019 Category: Pharmaceuticals Source Type: news

Govt considering to let US companies make medical devices in India
US has been pushing India to lift price caps on coronary stents and knee implants. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 28, 2019 Category: Pharmaceuticals Source Type: news

Strides Pharma Science arm gets USFDA nod for drug to treat overactive bladder
The approved product is a generic version of Vesicare tablets of Astellas Pharma US, Inc. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 27, 2019 Category: Pharmaceuticals Source Type: news

Strides Pharma suspends sale of Ranitidine tab in US
In a regulatory filing, the company said it has received an Information Request from the USFDA to provide test data related to NDMA impurities in ranitidine tablets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 27, 2019 Category: Pharmaceuticals Source Type: news