Founders seeking exit value Sequent Scientific at Rs 2,500 crore
Sequent ’s market cap as on Tuesday was Rs 1,670 crore. But the founders are seeking a control premium of 49.7% or 18-20x forward Ebitda multiple, valuing the company at Rs 2,100-2,500 crore, sources said. Some, however, worry that such expectations may turn out to be a potential deal breaker. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2019 Category: Pharmaceuticals Source Type: news

States told to restrain unlicenced e-pharmacies
The Drug Controller General of India (DCGI) has asked the state-level drug regulators to ensure that e-pharmacies don ’t sell medicines without a licence. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2019 Category: Pharmaceuticals Source Type: news

Strides Pharma gets tentative nod from USFDA for pain relieving drug
Strides Pharma Global Pte Ltd, Singapore, has received tentative approval for Diclofenac Potassium Softgel Capsules, 25 mg from the United States Food& Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2019 Category: Pharmaceuticals Source Type: news

E-pharmacies await govt to release regulations for the sector
"We want India to come up with a progressive e-pharmacy regulation. We want that as that would give a lot of clarity and confidence to the sector, whether it is investors, whether it is our business partners and vendors," 1mg Technologies Founder and CEO Prashant Tandon told reporters here. The government is yet to release the final notification. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2019 Category: Pharmaceuticals Source Type: news

Siddharth Mittal takes over as CEO, Joint MD of Biocon
Mittal takes over from Arun Chandavarkar who retired as chief executive and joint MD of the company on November 30. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2019 Category: Pharmaceuticals Source Type: news

Volume with low cost is Biocon Biologics ’ big plan
The Biocon subsidiary will chart a path that ensures high volumes and low costs, unlike competitors. The company plans to create an ecosystem where patients not only have access to the right medicine, but also gets the right care without always reaching a hospital. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2019 Category: Pharmaceuticals Source Type: news

Sun Pharma gets partial relief from US court in litigation involving three generic drugs
Drug major Sun Pharma is a defendant in a multi-district litigation brought by various classes of plaintiffs in the US District Court (District of Massachusetts), alleging a delay in the market entry for three generic drugs -- Valganciclovir, Valsartan and Esomeprazole. The company said it would continue to vigorously defend against all claims. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2019 Category: Pharmaceuticals Source Type: news

Biocon, Mylan launch cancer drug in US market
Ogivri, available in a 420mg multi-dose vial and a 150mg single-dose vial, will be used for treatment of all types of breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2019 Category: Pharmaceuticals Source Type: news

Roche India head Lara Bezerra set to exit
A Roche India spokesperson confirmed the development and said an announcement for a new India head will be made soon. “Dec. 1 will be the date for Lara to end the assignment. During her tenure at Roche India, Lara successfully led the organization with passion and commitment and shaped the culture of the organization,”the statement added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 28, 2019 Category: Pharmaceuticals Source Type: news

Pharma Inc agrees to cap margins on non-price control drugs at 30%
A consensus to this effect was reached at a meeting held on Friday between the drug pricing regulator, pharma lobby groups and industry associations, said people present at the meeting. The 30% cap on trade margins was preferred over other proposals such as imposing a flat 100% trade margin on all medicines, including those within price control. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 27, 2019 Category: Pharmaceuticals Source Type: news

Biocon, Mylan get USFDA nod for pegfilgrastim drug substance licence
This additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable the biotechnology major to enable its arm Biocon Biologics and Mylan to scale up capacity multi-fold and address the growing market opportunities in US and other global markets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 27, 2019 Category: Pharmaceuticals Source Type: news

Glenmark Pharma gets USFDA nod for diabetes management drug
"Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the United States Food& Drug Administration (USFDA) for metformin hydrochloride extended release tablets USP, 500 mg and 1000 mg, the generic version of Glumetza extended release tablets, 500 mg and 1,000 mg, of Salix Pharmaceuticals Inc," the drug maker said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 26, 2019 Category: Pharmaceuticals Source Type: news

Indoco Remedies receives EIR from USFDA
Indoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the inspection carried out by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation) from August 5 to August 9, 2019," the filing said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 26, 2019 Category: Pharmaceuticals Source Type: news

US health regulator finds Silvassa unit non-compliant with CGMP: Ipca Labs
The company said that since this manufacturing facility is already under USFDA import alert and presently not doing any US business, this will have no impact on company's current on-going business activities. The USFDA inspection of its Piparia (Silvassa) formulations manufacturing unit in August resulted in three observations. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 26, 2019 Category: Pharmaceuticals Source Type: news

Religare fraud: Court refuses bail to Shivinder Mohan Singh
Opposing his bail, EOW had alleged that documents collected during investigation reflect a pivotal role of Shivinder in conspiracy with co accused Malvinder Mohan Singh and other co- accused to “misappropriate funds of such large magnitude”. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 26, 2019 Category: Pharmaceuticals Source Type: news

Need Malvinder Singh's custody to confront him with docs, witnesses in RFL scam, ED tells HC
The trial court had on November 23 dismissed the agency's application for further custodial interrogation of Singh and Godhwani and had sent them to judicial custody till December 7. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 26, 2019 Category: Pharmaceuticals Source Type: news

Booster dose for Indian medical device makers
The stipulation for US or European regulatory approval excludes local manufacturers from tenders and to level the playing field, it is recommended that there should be preference for Make in India products during public procurement, the Department of Pharmaceuticals said in a recent letter to the states (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 26, 2019 Category: Pharmaceuticals Source Type: news

Aurobindo Pharma aims to become debt free in 3 years sans Sandoz deal
In September last year, the USD three billion drug maker said its US subsidiary entered into an agreement to acquire commercial operations and three manufacturing facilities in America from Sandoz Inc, USA, a Novartis Division, for USD 900 million. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 24, 2019 Category: Pharmaceuticals Source Type: news

USFDA finds several violations in Aurobindo sterile injections unit
FDA investigators have observed violations in sterilisation process to prevent microbial contamination and shortcomings in facility management procedures along with lapses in the design of the manufacturing plant. The same unit had come under the FDA radar in March 2018. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 23, 2019 Category: Pharmaceuticals Source Type: news

Delhi court seeks report from Delhi police on Malvinder Singh's complaint against Radha Soami Satsang Beas chief
Malvinder ’s lawyer Manu Sharma today approached the court with a plea that there has been no headway in the case filed in February. Malvinder had accused that his brother Shivinder, the family members of Dhillon had misappropriated the funds of RHC Holding, the company that owned assets of the group and ha d sought Rs 8,742 crore in compensation. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 21, 2019 Category: Pharmaceuticals Source Type: news

Chinese strategy: Dr Reddy's outsources part manufacturing to local parties
The company which won the tender to market Olanzapine drug in China, is expected to launch it beginning next year, the official said. The products are manufactured either in the plant owned by KRRP in China, or partners in China, or in India by Dr. Reddy's, the official further said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 21, 2019 Category: Pharmaceuticals Source Type: news

Laurus Labs gets 3 observations from USFDA for Visakhapatnam facility
The company has completed the pre approval inspection (PAI) for an active pharmaceutical ingredient (API) manufactured at its Units 1&3, located at Visakhapatnam by the United States Food and Drug Administration, Laurus Labs said in a filing to the BSE. The inspection was completed with three observations, 'which are procedural in nature'. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 21, 2019 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets USFDA nod for Isosorbide Dinitrate tablets, Desonide Cream
The USFDA has approved to market Isosorbide Dinitrate tablets manufactured by drug firm Zydus Cadila. The drug firm has also received final approval from US health regulator for Desonide Cream, used to treat a variety of skin conditions like eczema, dermatitis, allergies and rash, the company said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 21, 2019 Category: Pharmaceuticals Source Type: news

NCLAT gives 30 days more to Sterling Biotech promoters to settle dues
A three-member bench headed by Chairperson Justice S J Mukhopadhaya also said the Enforcement Directorate will probe and ascertain whether the money paid by the promoters is not from proceeds of crime. The promoters of the company include absconding Nitin Jayantilal Sandesara and Chetankumar Jayantilal Sandesara. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 19, 2019 Category: Pharmaceuticals Source Type: news

Panacea Biotec appoints Susheel Umesh as Chief Executive of domestic formulations
Susheel Umesh brings in 27 years of experience, deep understanding of pharmaceutical industry, the company said. Panacea Biotec is a leading pharmaceutical and biotechnology company with established research, manufacturing and marketing capabilities. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 19, 2019 Category: Pharmaceuticals Source Type: news

Niti Aayog has not rejected proposal to bring medical devices under CDSCO: Govt
Responding to a question in the Rajya Sabha, Minister of State for Health Ashwini Choubey also said that no proposal has been approved regarding establishment of a separate statutory body on the lines of the Food Safety and Standards Authority of India (FSSAI) for the regulation of medical devices. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 19, 2019 Category: Pharmaceuticals Source Type: news

Govt to initiate talks with stakeholders on drug trade margins
The Department of Pharmaceuticals along with the Drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA) will discuss the issue of TMR with the stakeholders, in an effort to reduce prices of medicines& medical devices. The trade margin is the difference between the price at which the manufacturers/importers sell to stockists and the price charged to consumers. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 19, 2019 Category: Pharmaceuticals Source Type: news

Advent set to buy controlling stake in Bharat Serum
Kotak PE and OrbiMed together that hold 23% stake in Mumbai-based biopharma company Bharat Serums and Vaccines (BSV) are exiting through this sale. The rest of the stake is with the Daftary family who are relinquishing control but will stay on as a minority partner, said people in the know. Advent will become the largest shareholder in the company. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 18, 2019 Category: Pharmaceuticals Source Type: news

Frequent FDA inspections slow down Indian pharma exports, says GV Prasad
GV Prasad, Chairman, CII National Committee on Pharmaceuticals said that everybody should up their game in terms of quality, systems, discipline, integrity of data. All there are important things for the industry. He added that the effect of frequent inspections of Indian pharma manufacturing plants by the FDA and measures to be taken to reduce the impact. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 18, 2019 Category: Pharmaceuticals Source Type: news

RFL case: Court extends ED custody of ex-Fortis Healthcare promoter Malvinder Singh
Special Judge extended the ED custody of both Malvinder Singh and former CMD of Religare Enterprises Ltd Sunil Godhwani till November 23 on a plea moved by agency's special public prosecutor Nitesh Rana. The ED had taken both the accused in its custody on November 14 inside the jail, where they were lodged in a case filed by the Delhi Police in relation to the alleged scam. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 18, 2019 Category: Pharmaceuticals Source Type: news

Illegal cancer drugs from Bangladesh flood local market
Illegal import of drugs from Bangladesh and other neighbouring countries have further added to the woes of pharmaceutical companies. Experts suggest a thriving ‘grey’ market of fake and unapproved copies of Big Pharma’s oncology and hepatology medicines, and some under patent protection. The drugs are smuggled, hence exact numbers are unavailable. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 18, 2019 Category: Pharmaceuticals Source Type: news

USFDA pulls up Mylan for manufacturing violations at Andhra plant
In a warning letter issued to the company's CEO Heather Bresch, the US Food and Drug Administration (USFDA) said inspectors during May 27 to June 5, this year found significant deviations from standard manufacturing practices at the company's Unit 8 in G Chodavaram village in Vizianagaram. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 18, 2019 Category: Pharmaceuticals Source Type: news

SC holds former Ranbaxy promoters Malvinder, Shivinder Singh guilty of contempt of court
A bench comprising Chief Justice Ranjan Gogoi and Justice Deepak Gupta held the former Ranbaxy promoters guilty of contempt of court and said that they had violated its earlier order by which the sale of their controlling stakes in Fortis Group to Malayasian firm IHH Healthcare was put on hold. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 15, 2019 Category: Pharmaceuticals Source Type: news

Radha Soami chief admits to financial dealings with Singh brothers
According to a 74 page affidavit filed in the High Court, Dhillon has said that in 2010, RHC holdings Ltd (respondent 19) through Singh brothers had approached him to assist them in subscribing for the rights issue, suggesting that they would finance Dhillons to subscribe to the rights issue. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 14, 2019 Category: Pharmaceuticals Source Type: news

Bharat Biotech's subsidiary Chiron Behring launches anti-rabies vaccine
“In our ongoing commitment to address the supply shortages of rabies vaccine, we are making additional investments to increase production capacities to over 15 million doses annually,” added Krishna Ella, CMD, Bharat biotech International Ltd. The vaccine is presently manufactured at the WHO pre -qualified facility in Ankleshwar in Gujarat. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 13, 2019 Category: Pharmaceuticals Source Type: news

Bharat Biotech launches anti-rabies vaccine ChiroRab, becomes largest rabies shot manufacturer
“In our ongoing commitment to address the supply shortages of rabies vaccine, we are making additional investments to increase production capacities to over 15 million doses annually,” added Krishna Ella, CMD, Bharat biotech International Ltd. The vaccine is presently manufactured at the WHO pre -qualified facility in Ankleshwar in Gujarat. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 13, 2019 Category: Pharmaceuticals Source Type: news

Biocon Biologics debuts in Asia IP Elite list
Biocon, the Bengaluru-headquartered bio-pharma firm and the parent company for Biocon Biologics, has has been recognised as the ASIA IP ELITE for the fourth year in a row. Biocon ’s subsidiary received this award at the recently concluded IP Business Congress Asia in Tokyo, Japan. Biocon Biologics has a product pipeline of 28 molecules. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 12, 2019 Category: Pharmaceuticals Source Type: news

Bengalurean ’s anti-cancer kit a breakthrough: US
The US Food and Drug Administration (FDA) ’s Centre for Devices and Radiological Health has designated a medical invention by a Bengaluru-based scientist as a “breakthrough device” in liver, pancreatic and breast cancer treatment. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 12, 2019 Category: Pharmaceuticals Source Type: news

Glenmark recalls over 2 lakh cartons of product in US
The ongoing voluntary class II recall is on account of defective delivery system with "complaints for difficulty in pushing the plunger of the applicator" (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 10, 2019 Category: Pharmaceuticals Source Type: news

Sun Pharma ex-employee alleges US Law violation, discrimination
Sandra Hagenbrock, who was national account director at Sun in the US and employed there from February 2016 to July 2019, alleged the company asked her to carry out off-label promotions of drugs, which she said was prohibited by federal laws. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 9, 2019 Category: Pharmaceuticals Source Type: news

New policy likely to resolve drug name anomaly
The government has geared up to resolve the confusion, restricting companies from using same brand names for different drugs. The health ministry has proposed to make an amendment in the Drugs and Cosmetics Rules. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 9, 2019 Category: Pharmaceuticals Source Type: news

Strides Pharma relaunches Ranitidine tablets in US
The company had suspended sales of its generic Ranitidine tablets after the USFDA found contamination in some Ranitidine tablets sold by various companies with potentially cancer causing impurities, NDMA. Strides said now the drug meets the limits prescribed by the US drug regulator. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 8, 2019 Category: Pharmaceuticals Source Type: news

Ranbaxy case: Radha Soami chief seeks exemption from court appearance
The court had in October ordered Gurinder Singh Dhillon along with his wife Shabnam, sons Gurkirat and Gurpreet and daughter-in-law Nayan Tara to be personally present in the court on November 14, after Dhillon and his family members had said that they did not owe any money to RHC Holding Pvt Ltd, promoted by Malvinder and Shivinder Singh. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 8, 2019 Category: Pharmaceuticals Source Type: news

GoM meets to discuss regulating e-pharmacies
The GoM was set up after government failed to push the proposal to legalise online pharmacies within 100 days of Modi govt ’s second term, following opposition from the brick and mortar pharmacies. “The first meeting of GoM to regulate e-pharmacies was held on October 30." The health ministry made a presentation, explaining its position on the issue. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 6, 2019 Category: Pharmaceuticals Source Type: news

Regulator waives off clinical trials, clears Sanofi TB Drug
“We have recently received final approval for rifapentine from the Indian regulatory authorities. Rifapentine is now officially registered in India,” Thibaud Lefort, Sanofi’s global health business chief, told ET on the sidelines of the 50th Union World Conference of Lung Health in Hyderabad. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 6, 2019 Category: Pharmaceuticals Source Type: news

Britain's AstraZeneca to distribute Sun Pharma cancer drugs in China
This comes after AstraZeneca said it was launching a new fund with China International Capital Corp to invest $1 billion in China's healthcare sector, as it expands its research work in the country. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 6, 2019 Category: Pharmaceuticals Source Type: news

Now, antacids must carry ‘kidney injury’ warning
Now the anti-acidity pills will carry a side-effect warning of 'acute kidney injury' as a part of their package insert leaflets, following the directive issued by India ’s Drugs Controller General. Recent studies on anti-acidity pills have pointed out that there can be serious after-effects due to prolonged use like long-term kidney damage. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 6, 2019 Category: Pharmaceuticals Source Type: news

Aurobindo Pharma under USFDA scrutiny
Aurobindo has seen intense scrutiny on the manufacturer process of valsartan, an anti-hypertension drug, that was found to contain carcinogenic impurities. Apart from Aurobindo, those impurities were detected in several other batches manufactured by drug makers. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 5, 2019 Category: Pharmaceuticals Source Type: news

Experts are mulling to group antibiotics into categories to combat misuse
The WHO in its revision exercise of antibiotics have grouped them into three categories – access, watch and reserve. WHO recommends that antibiotics in the access group be available “at all times” as treatments for a wide range of common infections. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 4, 2019 Category: Pharmaceuticals Source Type: news

Our drug Ranitidine is safe: Strides Pharma
Ranitidine is a commonly prescribed medicine for countering acidity and is on the WHO ’s Model List of Essential Medicines. In India, a host of companies including GalxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s and Sun Pharmaceuticals sell over 180 versions of the drug. Strides Pharma is likely to resume drug sale, following the report. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 4, 2019 Category: Pharmaceuticals Source Type: news