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Biocon's Breast Cancer Biosimilar Gets USFDA Panel Nod, Shares Surge

Biocon’s Breast Cancer Biosimilar Gets USFDA Panel Nod, Shares Surge

Biocon’s Breast Cancer Biosimilar Gets USFDA Panel Nod, Shares Surge

The older Mylan and Biocon drugs, said today that the Advisory Committee on Cancer Medicines (ODAC) of the United States Health Authority approval of trastuzumab biosimilar proposal recommended, indicated for the treatment of breast cancer.

In a filing with regulators, Biocon said the committee had voted 16-0 in support of eligible indications of the reference product.

“This vote is the first biosimilar trastuzumab proposal recommended by the committee,” he added.

Regarding development, Mylan President Rajiv Malik said: “We are delighted with ODAC’s recommendation to support the approval of Mylan’s biosimilar trastuzumab to increase affordability, competition and, above all, global access and use” .

CEO and CEO of Biocon joint Arun Chandavarkar, said: “We look forward to working with the FDA to obtain final approval to expand access to the affordable and high-quality treatment option for HER2 positive breast cancer.”

The two companies, in a joint statement, said the US Food and Drug Administration uses committees and charts to obtain advice from independent experts on various topics including product approval.

“The FDA generally follows the advice of ODAC to determine if a product should come on the market, even though they are not required to continue,” they added.

The biosimilar trastuzumab proposed by Mylan and Biocon is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.

Biocon shares rose 8.19% compared to Rs. 396,70 each on BSE.

Arun Jaitley urges Jammu and Kashmir to clear state GST Act for national rollout on July 1

Arun Jaitley urges Jammu and Kashmir to clear state GST Act for national rollout on July 1

Commodity prices will not increase with the new tax regime, Commerce Minister Nirmala Sitharaman said.

Arun Jaitley Urges Jammu and Kashmir to Eliminate GST Status Law for Nationwide Launch on July 1

Union Finance Minister Arun Jaitley on Tuesday urged the Jammu and Kashmir government, Mufti led by Mehbooba, to eliminate the State Property and Services Act prior to the enactment of the July 1 national law.

Jammu and Kashmir are the only ones that have not yet adopted the law. Jaitley said the failure of the application would put companies at a disadvantage and have a “negative impact” on the economy, the Hindu said.

Meanwhile, the Minister of Commerce and Industries, Nirmala Sitharaman, refuted the concern about rising commodity prices under the new regime. “There is no different explanation for the public and another for traders,” Sitharaman said. “It’s all the same. The price of basic necessities is not going to increase.”

In a letter to the Chief Minister, Jaitley would have suggested that the state uses its powers for a special statute under section 370 to give its approval without the authorization of the Assembly, the Times of India reported. The Popular Democratic Party party – the Bharatiya Janata Party government plans to end the stagnation in the Assembly before the nationwide launch, unidentified officials said.

The state will be a meeting of all parties to discuss the issue after a special session of the House on June 17, did not vote.

Implications for the state
The Finance Minister has warned the state government that the exclusion of the tax system would translate into higher prices of goods in the state, as well as an increase in taxes on goods leaving the state.

Jaitley said entrepreneurs would not be able to benefit from the credit option available under the new tax regime. “The GST is a tax based on fate … if the state of Jammu and Kashmir do not join the GST on July 1, dealers do not take into account the integrated GST in all purchases,” said Jaitley in his letter To the Mufti.

The Center began to accept registration applications from companies that still have to register with the Tax Network products and services.

Jaitley had said that the government had recorded nearly 65 lakh taxpayers on the network, The Hindu.

Once in the network, companies can use the common portal to file tax returns and pay taxes.

The Center has also delayed the launch of a role in the new tax regime that would make it compulsory for e-commerce players to deduct tax on payments made to suppliers.

The government led by the BJP said that small businesses using e-commerce platforms should not enroll in the network immediately.

The delay gives e-commerce platforms and suppliers more time to meet the requirements of the new law.

The Center has dismissed the claims of the Association of Indian Chambers of Commerce and the Ministry of Civil Aviation to postpone the implementation of the GST deployment.

Mumbai: Six prison officials booked for allegedly killing convict in Byculla jail

Mumbai: Six prison officials booked for allegedly killing convict in Byculla jail

The detainees had protested after the death of Manjula Shetya because she was assaulted and beaten by sexual jailers.

Mumbai: Six Prison Officials Charged with Murder Sentenced to Prison in Byculla

Five officers and a jailor at Byculla Prison, Mumbai, were set aside to assault and kill a detained Manjula Shetye sexually, the Hindustan Times reported Tuesday.

Shetye died on June 23 provoked a protest, and former media tycoon Indrani Mukerjea (pictured), who was jailed for killing his daughter Sheena Bora, was one of 200 women detained for committing a mutiny in the jail.

A witness has submitted a first briefing paper on the death of Shetye Nagpada police station. He said the six prison officials were brutally beaten and raped the 38-year-old prisoner to complain about two eggs and five slices of bread that lacked the morning ration.

The witness told police Shetye was first called in the private room of Manisha Pokharkar’s agent, Hindustan Times reported.

She was attacked there and returned to the barracks. Later, the female police officers Bindu Naikade, Waseema Shaikh, Shital Shegaonkar, Surekha Gulve and Aarti Shingne did strip and raped with a stick, or lathi.

Initially, no official was only arrived with Shetye said the FIR. Shetye was taken to the resident doctor after being unconscious in the bathroom. He died at the JJ Hospital.

The autopsy report said Shetye was about 11 to 13 blue, while Dean TP Lahane had told Hindustan Times that his lungs were damaged.

Meanwhile, police are likely to question Indrani Mukerjea about his role in the alleged prison riot.

Mukerjea said how Shetye was killed and alleged that prison officials had threatened sexual assault, NDTV reported. She will appear before a special CBI court on Wednesday.

His lawyer Gunjan Mangala also alleged that prison officials had assaulted Mukerjea. “The brown marks can be seen on Indrani Mukerjea’s body all over after being hit by prison officials,” Mangala told Tuesday in court, according to The Times of India.

Al Qaeda vows to target Indian Army officers who have the ‘blood of Kashmiris on their hands’

Al Qaeda vows to target Indian Army officers who have the ‘blood of Kashmiris on their hands’

In a 20-page document, the celebration of terror has accused India of “destroying the houses of Muslims, to weaken them in social status and to force them to convert to Hinduism.”

Al Qaeda vowed to target Indian army officers that the “Cashmere of blood in their hands”

Al Qaeda in the Indian subcontinent has said that it would target members of the Indian Army that “the blood of our Kashmiri brothers in their hands.”

The team has published a 20-page document entitled “Code of Conduct for Mujahideen in the Subcontinent,” listing their goals and objectives in India, Pakistan, Bangladesh and Myanmar.

“All military personnel are our target, whether in war zones or in barracks to their bases,” the document said.

“Even the holiday staff is not exempt due to their fight against the application of sharia and defending the system of infidelity.”

Accusing India of oppressing Muslims in Kashmir and across the country, AQIS – a branch of the global al Qaeda militant group established in 2014 – said the Indian state “also destroyed their [Muslim] homes, weakens the condition Social and forced to convert to Hinduism in “also said that India is a ‘strong ally’ of the United States, Russia and Israel ‘against jihadist and Islamic awakening throughout the region.”

AQIS has also accused India of “usurping” Muslim water from Bangladesh, destroying its agriculture and controlling the country’s trade and industry. “History shows that India always wants to live the Muslims of Bengal as slaves,” the document said.

In the 20-page document, the branch of Al Qaeda has listed the separatist Hindu organizations, the Indian army, the “blasphemers” and officials “genocide of the Muslims”, since the partition as the target. In Myanmar, it has classified the country’s army and armed Buddhist groups as a target ….

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